Bariatric surgery operating room with a laparoscopic-based visceral fat tissue aspiration system configured and operational for treating metabolic syndrome in human patients on an ambulatory basis

ABSTRACT

A bariatric surgery operating room configured and operational for treating metabolic syndrome in human patients on an ambulatory basis. The bariatric surgery operating room includes a set of trocars for creating laparoscopy portals through small incisions formed in a human patient&#39;s body while supported upon an operating table. A source of inert gas is provided for infusion into the abdominal region of the patient so as to cause tenting of the abdominal region and abdominal distension and tenting in a human patient suffering from obesity and likely to benefit from visceral fat removal within the body of the human patient. A laparoscope is inserted through a first one of said trocars and into the abdominal region of the human patient so that a surgeon can capture video images of the abdominal region of the patient, and display the captured video images within the view of the surgeon. A powered tissue aspiration instrument is inserted through a second one of the trocars and into the mesenteric region of the human patient. Gripping tools are inserted through a third and optionally fourth trocars installed in the patient&#39;s abdomen, for gripping anatomical structures in the mesenteric region during visceral fat tissue aspiration operations. The laparoscope is used to capture video images of the mesenteric region of the human patient during visceral fat tissue aspiration operations, and display video images to provide laparoscopic guidance to the surgeon while aspirating visceral fat tissue from the mesenteric region of the human patient so as to treat metabolic syndrome of the human patient in a minimally-invasive manner by reducing three or more risk factors associated with metabolic syndrome.

RELATED CASES

This Patent Application is a Continuation of co-pending application Ser.No. 15/700,090 filed Sep. 9, 2017, which is a Continuation ofapplication Ser. No. 13/315,230 filed Dec. 8, 2011, now U.S. Pat. No.9,833,279 granted Dec. 5, 2017; which is a Continuation of applicationSer. No. 12/850,786 filed Aug. 5, 2010, now U.S. Pat. No. 8,465,471granted Jun. 18, 2013; which is a Continuation-in-Part (CIP) ofco-pending application Ser. No. 12/462,596 filed Aug. 5, 2009, andco-pending application Ser. No. 12/813,067 filed Jun. 10, 2010; whereineach said Application is owned by Rocin Laboratories, Inc., andincorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION Field of The Invention

The present invention relates to a novel way of and means for treatingabdominal obesity, metabolic syndrome and Type II diabetes mellitus inhuman patients.

Brief Description of the State of Knowledge in the Art

In general, there are three kinds of fat in the human body: subcutaneousfat, intramuscular fat, and visceral fat.

Subcutaneous fat is found underneath the skin, and intramuscular fat isfound interspersed in skeletal muscle. Fat in the lower body, e.g. inthighs and buttocks, is subcutaneous. Visceral fat, also known as organfat or intra-abdominal fat, is located inside the peritoneal cavity,packed in between the internal organs and torso of the abdomen. Thereare several adipose tissue deposits of visceral fat in the human body,namely: mesenteric, epididymal white adipose tissue, and perirenaldeposits. [Adipose tissue as an endocrine organ Kershaw E E, Flier J S.J. Clin. Endocrinol. Metab. 89 (6): 2548-56 (2004).] An excess ofvisceral fat is known as central obesity, “belly fat,” the “pot belly”or “beer belly,” where the abdomen protrudes excessively.

Over 250 years ago, Johannes Baptista Morgagni described android obesityas increased intra-abdominal and mediastinal fat accumulation. Backthen, he recognized the association between visceral obesity,hypertension, hyperuricemia, atherosclerosis, and obstructive sleepapnea syndrome. [Historical perspective: visceral obesity and itsrelation to morbidity in Johannes Baptista Morgagni's ‘De sedibus etcausis morborum per anatomen indagata’ Enzi G, Busetto L, Inelmen E M,Coin A, Sergi G Int. J. Obes Relat Metab Disord 27: 534-535 (2003)]

Today, Morgagni's android obesity condition is now described asmetabolic syndrome, and is associated with insulin resistance andincreased risk of Coronary Heart Disease. The Metabolic syndrome is acondition defined by any three of five risk factors, one of which iswaist circumference (female waist >88 cm (>35″), male waist >102cm.(>40″). The others are triglycerides: (men <40mg/d1; women <50mg/dl), HDL cholesterol (≥110 mg/dl), blood pressure (≥130/≥85 mm Hg),and FBS (>150 ml/d1). [Dyslipidemia of central obesity and insulinresistance. Brunzell, J D, Hokanson, JE Diabetes Care: 22(3);Mediastinal fat, insulin resistance and hypertension. Sharma A MHypertension: 44:117 (2004)].

Over the past 40 years, the prevalence of obesity in the US increasedfrom 13% to 32%. In 2003-2004, 66% of U.S. adults were overweight orobese.

Abdominal obesity as measured by waist circumference and waist hip ratio(WHR) is an independent predictor of mortality. Marginally increasedwaist circumference is strongly associated with prevalent hypertensionin normal-weight and overweight adults. Also, there is a strongcorrelation between central (i.e. abdominal) obesity and cardiovasculardisease. [Effect of potentially modifiable risk factors associated withmyocardial infarction in 52 countries. Yusuf S, Hawken S, Ounpu S, DansT, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L,Lancet 364: 937-52 (2004).] Because of this, the WHR ratio has been usedas a measure of obesity and is an indicator or measure of the health ofa person, and the risk of developing serious health conditions. Researchshows that people with “apple-shaped” bodies (with more weight aroundthe waist) face more health risks than those with “pear-shaped” bodieswho carry more weight around the hips. [Waist-hip ratio should replaceBody Mass Index as an indicator of mortality risk in older people. Am.J. Clin. Nutrition (Aug. 12, 2006).]

A WHR of 0.7 for women and 0.9 for men have been shown to correlatestrongly with general health and fertility. Women within the 0.7 rangehave optimal levels of estrogen and are less susceptible to majordiseases such as diabetes, cardiovascular disorders and ovarian cancers.Men with WHR' s around 0.9, similarly, have been shown to be healthierand more fertile with less prostate cancer and testicular cancer.Studies show that 80 percent of women over the age of 18 have a WHR ofat least 0.9. This is a 40 percent increase since 2002, and it keepsincreasing.

Although maintaining a healthy weight is a cornerstone in the preventionof chronic diseases and premature death, maintaining a healthy waistsize should also be an important goal.

Markedly obese patients are typically directed towards diet and exerciseprograms, and failing that, presented with the option of bariatricsurgery or living with and dying from the increased morbidity ofobesity. After bariatric surgery, plastic surgeons perform skinexcisions of the redundant folds of tissue remaining on patients who hadlost 50-200 lbs. These post-bariatric surgery patients are frequentlynutritional cripples with hypoalbuminemia, cirrhosis, and renal stonesand suffer increased complications reflecting their impaired nutritionalstatus.

Traditional plastic surgical approaches have been cosmetic, targetedonly at removing (i) localized subcutaneous fat deposits in non-obese ormodestly obese patients, and (ii) the redundant folds of abdominal wallor pannus that remain after massive weight loss from gastric banding orintestinal bypass procedures.

Before subcutaneous visceral fat aspiration, combined hemostasis andanalgesia is achieved in the patient by infusing tumescent solutions oflactated Ringer's solution, containing dilute amounts of xylocaine andepinephrine. Performing tumescent visceral fat aspiration in this mannerallows increased volumes of fat to be removed and obviates the need forgeneral anesthesia which, in turn, facilitates outpatient surgery inoffice-based facilities. [Tumescent Technique Klein, J. Mosby (2000).]

Studies have now shown large volume subcutaneous fat aspiration andabdominoplasty as feasible alternatives for improving body shape.[Large-volume visceral fat aspiration and extensive abdominoplasty: afeasible alternative for improving body shape. Cardenas-Camarena L,Gonzalez L E Plast Reconstr Surg. 102: 1698-707 (1998).]

Clinical studies have shown large volumes of fat can be safely removedin serial visceral fat aspiration procedures performed at safeintervals. Pilot studies have also shown improvement in thecardiovascular risk profile with large volume subcutaneous visceral fataspiration. [Improvements in cardiovascular risk profile withlarge-volume visceral fat aspiration: a pilot study. Giese S Y, Bulan EJ, Commons G W, Spear S L, Yanovski J A. Plastic Reconstr Surg. 108510-21(2001).]

However, it should be noted that such large volume subcutaneous fataspiration approaches are still mainly cosmetic, as only the lessmetabolically active, subcutaneous fat is addressed and removed duringsuch procedures.

Recently, animal research has discovered that only the removal ofvisceral fat in mice has been shown to stop insulin resistance.[Visceral fat removal stops insulin resistance. Barzilai N. Diabetes 51:2951-2958 (2002).] Increased visceral fat shortens mammalian longevityand its removal lengthens it. [Visceral adipose tissue modulatesmammalian longevity. Muzumdar R., Allison D B, Huffman, D M, Xiaohui M,Einstein, FH, Fishman S, Poduval AD, McVei T, Keith, S W, Barzilai, N.Aging Cell 7(3) 438-440 (2008).] [The effect of fat removal on glucosetolerance is depot specific in male and female mice. Haifei S, Strader AD, Woods, S C, Seeley, R J Am. J. Physiol Endocrinol Metab 293:E1012-1020 (2007).]

Adipose tissue is a metabolically active tissue and serves as animportant endocrine organ. The hypertrophic fat cells of adipose tissuein obese patients produce increased quantities of leptin and tumornecrosis factor-a (TNF-a) and are less sensitive to insulin. Studieshave revealed effect of visceral fat aspiration on insulin resistanceand vascular inflammatory markers in obese women. Giugliano G, NicolettiG, Grella E, Giugliano F, Esposito K, Scuderi N, D'Andrea F. Br J PlastSurg. 2004 Apr; 57(3): 190-4.) The most important secreted products offat cells are leptin, resistin, tumor necrosis factor-a(TNF-a), andadiponectin. The first three products are increased in obese patients asa result of increased production by enlarged fat cells. In contrast,adiponectin, which improves glucose handling by peripheral tissues, ispresent at lower levels in obese patients [Bastard J P, Maachi M, vanNhieu J T, Jardel C, Bruckert E. Grimaldi A, Robert J J, Capeau J,Hainque B: Adipose tissue content correlates with resistance to insulinactivation of glucose uptake both in vivo and invitro. J Clin EndocrinolMetab 87:2084-2089, 2002; Borst SE: The role of TNF-alpha in insulinresistance. Endocrine23: 177, 2004; Fernandez-Real J M, Lopez-Bermejo A,Casamitjana R, et al.: Novel interactions of adiponectin with theendocrine system and inflammatory parameters. J Clin Endocrinol Metab88:2714-2718, 2003; Rashid M N, Fuentes F, Touchon R C, Wehner PS:Obesity and the risk for cardiovascular disease. Prey Cardiol6: 42-47,2003].

Hypertrophic fat cells present in the subcutaneous tissue of obesepatients generally produce increased quantities of secreted productssuch as leptin [Friedman J M: Obesity in the new millennium. Nature 404:632,2000] and TNF-a [Hotamisligil G S, Shargill N S, Spiegelman B M:Adi-pose expression of tumor necrosis factor-alpha: Direct role inobesity-linked insulin resistance. Science 259:87, 1993], but are lesssensitive to insulin in vivo and in vitro [Chlouverakis C, Hojnicki D:Effect of fat cell size on its sensitivity to insulin measured by a newmethod. Steroids Lipids Res 5:351,1974; Olefsky J M: Mechanism ofdecreased responsiveness of large adipocytes. Endocrinology 100:1169,1977].

Many studies assert that excising a large amount of subcutaneous fat bylarge-volume visceral fat aspiration (LVL) is metabolically safe [GieseS Y, Bulan E J, Commons G W, et al.: Improvements in cardiovascular riskprofile with large-volume visceral fat aspiration: A pilot study. PlastReconstr Surg 108:510, discussion 520, 2001; Gonzalez-Ortiz M,Robles-Cervantes J A, Cardenas-Camarena L, et al.: The effects ofsurgically removing subcutaneous fat on the metabolic profile andinsulin sensitivity in obese women after large-volume liposuctiontreatment. Horm Metab Res 34:446,2002; Robles-Cervantes J A, Yanez-DiazS, Cardenas-Camarena L: Modification of insulin, glucose, andcholesterol levels in nonobese women undergoing visceral fat aspiration.Ann Plast Surg 52:64,2004] and associated with improvement ininflammatory markers and insulin sensitivity in obese women [GiuglianoG, Nicoletti G, Grella E, et al.: Effect of visceral fat aspiration oninsulin resistance and vascular inflammatory markers in obese women. BrJ Plast Surg 57:190, 2004; Gonzalez-Ortiz M, Robles-Cervantes J A,Cardenas-Camarena L, et al.: The effects of surgically removingsubcutaneous fat on the metabolic profile and insulin sensitivity inobese women after large-volume visceral fat aspiration treatment. HormMetab Res 34:446,2002] and nonobese women [Robles-Cervantes J A,Yanez-Diaz S, Cardenas-Camarena L: Modification of insulin, glucose, andcholesterol levels in nonobese women undergoing visceral fat aspiration.Ann Plast Surg 5 2:64,2004]

Also, it is known that visceral fat cells within the abdomen have theirsecretions poured directly in to the portal blood circulation with amuch more profound effect on metabolism. Human mesenteric adipose tissuein obese diabetic subjects has high basal glycerol release and impairedisoproterenol stimulated glycerol release. The obesity-related geneexpressions in the mesenteric adipose tissue are up regulated,suggesting that the alterations of these genes in mesentery adiposedepot may play a critical role in insulin resistance of type 2 diabetesand metabolic syndrome. [Cell Physiol Biochem. 2008; 22(5-6):531-8. Epub2008 Dec 9.Human mesenteric adipose tissue plays unique role versussubcutaneous and omental fat in obesity related diabetes. Yang Y K, ChenM, Clements R H, Abrams G A, Aprahamian C J, Harmon C M.]

In Brazil, clinical trials are being carried out with partialomentectomy to determine the effect on insulin sensitivity. However,such studies have used direct surgical excision, posing high risk ofvascular injury, with concomitant bleeding and vascular compromise ofthe intestine. [Surgical removal of visceral fat tissue (omentectomy)associated to bariatric surgery: effect on insulin sensitivity. ClinicalTrials NCT00545805 University of Campinas, Brazil].

Thus, while there is great promise that the removal of visceral fat inthe mesenteric region of human patients stands to ameliorate themetabolic syndrome and abdominal obesity, and reduce morbidity due toobesity, there is a great need in the art for a new and improved methodof and apparatus for safely removing visceral fat in human patients,without employing conventional direct surgical excision techniques, andposing high risk of vascular injury with concomitant bleeding andvascular compromise of the intestine, associated with conventionalsurgical procedures and apparatus.

OBJECTS OF THE PRESENT INVENTION

Accordingly, it is a primary object of the present invention to providea new and improved method of and apparatus for safely removingmesenteric fat in human patients to ameliorate the metabolic syndrome,or abdominal obesity, while avoiding the shortcomings and drawbacks ofconventional surgical procedures and apparatus.

Another object of the present invention is to provide such an apparatusin the form of a laparoscopically-guided intra-abdominal visceral fataspiration system including a powered hand-supportable fat aspirationinstrument held by a surgeon and having an electro-cauterizing,irrigating and fiber-illuminating twin-cannula assembly for the saferemoval of visceral fat from the mesenteric region of a patient, througha small incision in the patient's body.

Another object of the present invention is to provide such alaparoscopically-guided intra-abdominal visceral fat aspiration system,designed for safely removing visceral fat from the mesenteric region ofa patient.

Another object of the present invention is to provide such alaparoscopically-guided intra-abdominal visceral fat aspiration system,wherein twin-cannula assembly support bipolar electro-cauterizationabout the aspiration aperture of a moving inner cannula, supported in astationary outer cannula connected to the hand-supportable housing ofthe instrument.

Another object of the present invention is to provide a novel method ofand apparatus for performing laparoscopic mesenteric visceral fataspiration for ameliorating the metabolic syndrome, or abdominal obesityof the patient.

Another object of the present invention is to provide such a methodcomprising the steps of inserting a laparoscopic instrument and anelectro-cauterizing visceral fat aspiration instrument into themesenteric region of a patient, for the purpose of safely removingvisceral fat to ameliorate the metabolic syndrome, or abdominal obesityof the patient.

Another object of the present invention is to provide a novel method oflaparoscopically-guided intra-abdominal visceral fat aspiration,involving the simultaneously infusion of a tumescent solution into themesenteric region of treatment, while synchronizing that infusion withthe forward or return (“action”) stroke of the inner cannula of the twin(dual) cannula assembly of the instrument.

Another object of the present invention is to provide a novel system forremoving both subcutaneous and visceral fat deposits in a minimallyinvasive manner.

A further object of the present invention is to provide a novel methodof minimally invasive visceral fat aspiration which is equallyapplicable to both subcutaneous and visceral fat deposits.

Yet a further object of the present invention is to provide a novelmethod of a lowering of the waist-to-hips circumference ratio, atreatment for and amelioration of type II diabetes mellitus, effect afavorable effect on metabolism as may be comprised of an increasedinsulin sensitivity, lowered fasting blood sugar, a lowering of bloodpressure (particularly diastolic), an improvement in the lipid profile(lowered cholesterol, raising HDL, lowered triglycerides, lowered serumadipocytokine (Leptin) and inflammatory markers (TNF-α=tumor necrosisfactor, resistin, IL-6 and IL-9), and by doing so effect a decrease ininsulin resistance and reduce the risk of coronary artery diseaseassociated with metabolic syndrome.

Another object of the present invention is to provide a method oftreating type II diabetes by way of selected removal of visceral fatcells and components contained therein (e.g. fat, adipocytokine (Leptin)and inflammatory markers (TNF-α=tumor necrosis factor, resistin, IL-6and IL-9), to improve the sensitivity of tissue cells to insulin.

Another object of the present invention is to provide a powered visceralfat aspiration instrument employing a twin (dual) cannula assembly,having a moving aspiration aperture that reciprocates over a range ofabout ¼″ to about 1 ″ which is appropriate to the thickness ofmesenteries and omental fat deposits.

Another object of the present invention is to provide a powered visceralfat aspiration instrument employing a twin-cannula assembly supportingbipolar electro-cauterization of targeted visceral fat target beingaspirated through the reciprocating inner aspiration aperture, in a safeand effective manner.

Another object of the present invention is to provide a powered visceralfat aspiration instrument employing a twin-cannula assembly which isdriven is such as manner to substantially reduce vibration ordisturbances which might be caused by the positioning of the instrumentand thus its associated vacuum tubing, when repositioning of theaspirating cannula within visceral fat tissue.

Another object of the present invention is to provide a powered visceralfat aspiration instrument having a small size and footprint therebyfacilitating its use in a laparoscopic procedure where multiple viewingand retracting instruments are inserted into key hole incisions in thepatient abdomen and the added bulk would be detrimental and impedeadoption.

Another object of the present invention is to provide a powered visceralfat aspiration instrument employing a twin-cannula assembly whichsupports simultaneous fluid irrigation and visceral fat aspiration aboutthe moving aspiration aperture, in order to achieve a sump affectfacilitating aspiration through the twin-cannula assembly.

Another object of the present invention is to provide a powered visceralfat aspiration instrument employing a twin-cannula assembly during alaparoscopic visceral fat aspiration procedure, which prevents theescape of compressed carbon dioxide (used to distend the patient'sabdomen during the procedure) through the instrument, or its cannulaassembly, or through the incision through which it is placed, other thanthrough the inner cannula itself as a result of fat aspiration throughthe inner cannula aperture(s).

Another object of the present invention is to provide a coaxially-drivenvisceral fat aspiration instrument employing a twin-cannula assemblythat performs visceral fat aspiration operations in a mechanicallyassisted manner.

Another object of the present invention to provide a visceral fataspiration instrument system which comprises a hand-supportable fataspiration instrument having a hand-supportable housing with astationary tubing connector provided at the rear of the housing andreceiving a length of flexible tubing connected to a vacuum source, andincluding a twin-cannula assembly coupled to a cannula drive mechanismdisposed within the hand-supportable housing and powered by an externalpower source (e.g. electrical power signals, pressurized air-streams,etc.) so as to periodically exert forces on the cannula base portionalong the longitudinal axis of the the cannula assembly (i.e. coaxiallyexerted on the cannula base portion) and cause the hollow inner cannulabase portion to reciprocate within the cylindrical (inner cannula baseportion) guide tube, while tissue is being aspirated along the cannulalumen, through the lumen formed in the cannula base portion, through thecylindrical guide tube and through the stationary tubing connector,along the flexible tubing towards the vacuum source.

Another object of the present invention is to provide a visceral fataspiration instrument system which comprises a hand-supportable fataspiration instrument and a single-type cannula assembly, wherein thehand-supportable fat aspiration instrument includes (i) ahand-supportable housing having (i) a front portion and a rear portionaligned along a longitudinal axis, (ii) an interior volume and acylindrical guide tube mounted within the interior volume, (iii) acannula drive mechanism disposed adjacent the cylindrical guide tube,and (iv) a stationary tubing connector coaxially mounted to the rearportion of the hand-supportable housing along the longitudinal axis,connected to the cylindrical guide tube, and having an exteriorconnector portion permitting a section of flexible aspiration tubing tobe connected at its first end to the exterior connector portion, andwhere the second end of the section of flexible tubing is connected to avacuum source.

Another object of the present invention is to provide a visceral fataspiration instrument system which comprises a hand-supportable fataspiration instrument and a twin-type cannula assembly.

An even further object of the present invention is to provide such a fataspiration instrument which can be driven by pressurized air orelectricity.

A further object of the present invention is to provide such a visceralfat aspiration instrument, in which the cannula assembly is disposable.

An even further object of the present invention is to provide animproved method of performing visceral fat aspiration, in which one ofthe cannulas of the cannula assembly is automatically reciprocated backand forth relative to the hand-holdable housing, to permit increasedcontrol over the area of subcutaneous tissue where fatty and other softtissue is to be aspirated.

Another object of the present invention is to provide a power-assistedvisceral fat aspiration instrument, with a means along the cannulaassembly to effect hemostasis during visceral fat aspiration proceduresand the like, using RF-based electro cauterization.

Another object of the present invention is to provide an air-poweredtissue-aspiration (e.g., visceral fat aspiration) instrument system,wherein the powered visceral fat aspiration instrument has an innercannula that is automatically reciprocated within a stationary outercannula by electronically controlling the flow of pressurized airstreams within a dual-port pressurized air cylinder supported within thehand-supportable housing of the instrument.

Another object of the present invention is to provide such anair-powered visceral fat aspiration instrument system, wherein digitalelectronic control signals are generated within an instrument controllerunit and these control signals are used to generate a pair ofpressurized air streams within the instrument controller which are thensupplied to opposite ends of the dual-port pressurized air cylinderwithin the powered visceral fat aspiration instrument.

Another object of the present invention is to provide such anair-powered visceral fat aspiration instrument system, wherein the rearend of the powered visceral fat aspiration instrument has a pressurizedair-power supply-line connector, and an electrical control signalconnector.

Another object of the present invention is to provide such anair-powered visceral fat aspiration instrument system, wherein thehollow inner cannula base portion of cannula assembly inserts into afront accessible port in the hand-supportable housing, while theaspiration tubing is connected to the stationary tube connector providedat the rear portion of the hand-supportable housing.

Another object of the present invention is to provide such anair-powered tissue-aspiration instrument system, wherein an intelligentinstrument controller is used to supply air-power to the inner cannulareciprocation mechanism within the hand-supportable instrument, whilecommunicating control signals between the instrument and its intelligentcontroller.

Another object of the present invention is to provide such antissue-aspiration instrument system with an alternativeelectro-cauterizing dual cannula assembly, wherein a stream ofirrigation fluid is automatically pumped from the base portion of theouter cannula to the distal portion thereof, along a micro-sized fluidconduit formed along the surface walls of the outer cannula, andreleased into the interior distal portion of the outer cannula through asmall opening formed therein, for infiltration and irrigation of tissueduring aspiration in order to facilitate pump action.

These and other objects of the present invention will be described ingreater detail hereinafter in the claims to invention appended hereto.

BRIEF DESCRIPTION OF THE DRAWINGS

The above Objects of the Present Invention will be more fully understoodwhen taken in conjunction with the following Figure Drawings, whereinlike elements are indicated by like reference numbers, wherein:

FIG. 1 is a system block diagram of the laparoscopically-guided bipolarpower-assisted twin-cannula visceral fat aspiration system of thepresent invention, showing an obese patient in an operating roomundergoing a mesenteric visceral fat aspiration procedure carried outusing the same in accordance with the principles of the presentinvention;

FIG. 2 is a perspective view of a first illustrative embodiment of thebipolar electro-cauterizing twin-cannula visceral fat aspirationinstrumentation system of the present invention, depicted in the systemof FIG. 1, and shown comprising (i) a hand-supportable fat aspirationinstrument having (i) a hand-supportable housing with a stationarytubing connector provided at the rear of the housing and receiving alength of flexible tubing connected to a vacuum source and connecting tothe cylindrical cannula base portion guide tube, and a twintumescent-type cannula assembly having an inner cannula coupled to anpneumatically-powered cannula drive mechanism disposed within thehand-supportable housing and powered by a source of pressurized air orother gas, while its stationary outer cannula is releasably connected tothe front portion of the hand-supportable housing, and (ii) a systemcontroller for controlling the electro-cautery, irrigation andillumination functions supported by the fat aspiration instrument;

FIG. 2A1 is a perspective view of the air-powered fat aspirationinstrument shown in FIG. 2, having a twin-cannula assembly supportingthree-functions (i.e. tumescent infusion, electro-cautery andvariable-spectrum illumination) about the aspiration aperture duringvisceral fat aspiration operations;

FIG. 2A2 is a partially exploded diagram of the fat aspirationinstrument shown in FIG. 2A1, showing its hand-supporting housing, inwhich its cylindrical (cannula base portion) guide tube and air-powereddriven mechanism are installed, while its cannula base portion, cannulaand cannula lock nut are shown disassembled outside of thehand-supportable housing;

FIG. 2B is a cross-sectional view of the hand-supportable fat aspirationinstrument shown in FIG. 2A1;

FIG. 2C is a perspective view of the multi-function twin-cannulaassembly of the present invention employed on the instrument shown inFIGS. 2A and 2A1;

FIG. 2D1 is a perspective view of the outer cannula component of thetwin-cannula assembly of FIG. 2C, constructed of stainless steel tubingcoated with a white-colored PFA (Dupont Teflon®) coating, and showingits integrated irrigation port and irrigation channel, and itsintegrated fiber-optic port and fiber-optic channel;

FIG. 2D2 is an elevated side view of the outer cannula component of thetwin-cannula assembly of FIG. 2D1, showing electro-cautery contacts onthe base portion of the outer cannula to which RF signal cables areconnected;

FIG. 2D3 is a first partially cut-away perspective view of the distal(tip) portion of the outer cannula component of the twin-cannulaassembly of FIGS. 2D1 and 2D2, illustrating that the fiber carrying theillumination source terminates at the outer aspiration aperture to thefield of aspiration about the aspiration aperture, and irrigation entersinto the bullet tip area of the outer cannula;

FIG. 2D4 is a second partially cut-away perspective view of the distal(tip) portion of the outer cannula component of the twin-cannulaassembly of FIGS. 2D1 and 2D2, illustrating that the fiber carrying theillumination source terminates at the outer aspiration aperture to thefield of aspiration about the aspiration aperture, and irrigation entersinto the bullet tip area of the outer cannula;

FIG. 2E1 is a first perspective view of the base portion of the outercannula component of the bipolar electro-cauterizing cannula assemblyshown in FIG. 2C;

FIG. 2E2 is a second perspective view of the inner cannula base portionof the outer cannula component employed in the bipolarelectro-cauterizing cannula assembly shown in FIG. 2C;

FIG. 2E3 is a plan view of the base portion of theelectrically-conductive outer cannula component of the bipolarelectro-cauterizing cannula assembly shown in FIG. 2C, revealing its setof radially arranged electrical contacts disposed about the central axisof the outer cannula base portion, while the inner cannula base portionis slidably received within the cylindrical guide structure within thehousing, so as to enable electrical contact between theelectrically-conductive inner cannula and radially-arranged electricalcontacts;

FIG. 2E4 is a perspective view of the outer cannula base portion shownin FIG. 2E3;

FIG. 2E5 is an exploded view of the outer cannula base portion shown inFIGS. 2E1 through 2E4;

FIG. 2F is a schematic diagram for the system controller employed by thefirst illustrative embodiment of the fat aspiration instrumentationsystem of FIG. 2A, supporting electro-cauterizing, irrigation andilluminating functions about the outer aspiration aperture of the fataspiration instrument;

FIG. 2G is a flow chart describing the operation of the infusion pump ofFIG. 2A in cooperation with irrigating electro-cauterizing visceral fataspiration instrument illustrated in FIGS. 2A through 2F;

FIG. 2H shows a cautery control program written in programming language,describing when to open and close the cautery relay switch employedwithin the electro-cautery RF power signal generation module of thesystem controller;

FIG. 3 is a perspective view of a second illustrative embodiment of thebipolar electro-cauterizing twin-cannula visceral fat aspirationinstrumentation system of the present invention, depicted in the systemof FIG. 1, and shown comprising (i) a hand-supportable fat aspirationinstrument having (i) a hand-supportable housing with a stationarytubing connector provided at the rear of the housing and receiving alength of flexible tubing connected to a vacuum source and connecting tothe cylindrical cannula base portion guide tube, and a twintumescent-type cannula assembly having an inner cannula coupled to anelectrically-powered cannula drive mechanism disposed within thehand-supportable housing and powered by a source of electrical power,while its stationary outer cannula is releasably connected to the frontportion of the hand-supportable housing, and (ii) a system controllerfor controlling the electro-cautery, irrigation and illuminationfunctions supported by the fat aspiration instrument;

FIG. 3A is a perspective view of the electromagnetically-powered fataspiration instrument shown in FIG. 3, having a twin-cannula assemblysupporting three-functions (i.e. tumescent infusion, electro-cautery andvariable-spectrum illumination) about the aspiration aperture duringvisceral fat aspiration operations;

FIG. 3B is a perspective view of the multi-function twin-cannulaassembly of the present invention employed on the instrument shown inFIGS. 2A and 3A, showing electro-cautery contacts on the base portion ofthe outer cannula to which RF signal cables are connected;

FIG. 3C is a first partially cut-away perspective view of the distal(tip) portion of the outer cannula component of the twin-cannulaassembly of the present invention, illustrating its fiber carrying theillumination source to the field about the outer aspiration aperture,and irrigation channel conducting irrigation fluid to the bullet tiparea of the outer cannula;

FIGS. 3D1 through 3D8 show a series of exploded views of the bipolarelectro-cauterizing fat aspiration instrument of the present invention,showing its components disassembled;

FIG. 3E is a partially-cutaway cross-sectional view of the bipolarelectro-cauterizing fat aspiration instrument taken along line 3F-3F inFIG. 3A;

FIG. 3F1 is a perspective view of the back housing plate employed in thehand-supportable instrument;

FIG. 3F2 is a perspective view of the cylindrical guide tube supportingits first and second electromagnetic coils;

FIG. 3F3 is an elevated side view of the cylindrical guide tubesupporting its first and second electromagnetic coils;

FIG. 3F4 is a perspective partially-cutaway view showing the connectionof the two electromagnetic coils to the contact plug employed in thehand-supportable fat aspiration instrument of the present inventionillustrated in FIG. 3A;

FIG. 3F5 is schematic diagram of a two coil push-pull type of circuitfor enabling the cannula drive mechanism employed in thehand-supportable fat aspiration instrument of the present inventionillustrated in FIG. 3A;

FIG. 3G1 is a sectional-view of a second embodiment of thehand-supportable fat aspiration instrument of FIG. 3A, showing acylindrical (cannula base portion) guide tube supporting threeelectromagnetic coils used to realize the cannula drive mechanismemployed in the fat aspiration instrument;

FIG. 3G2 is schematic diagram of a three coil push-pull type of circuitfor enabling the cannula drive mechanism employed in the secondembodiment of the hand-supportable fat aspiration instrument of thepresent invention illustrated in FIG. 3A;

FIG. 3H is a schematic diagram for the system controller employed by thesecond illustrative embodiment of the fat aspiration instrumentationsystem of FIG. 3A, supporting electro-cauterizing, irrigation andilluminating functions about the outer aspiration aperture of the fataspiration instrument;

FIG. 3I shows a cautery control program written in programming language,describing when to open and close the cautery relay switch employedwithin the electro-cautery RF power signal generation module;

FIG. 4 is a perspective view of the in-line fat sampling device of thepresent invention connected between the vacuum source and thetwin-cannula visceral fat aspiration instrument of the presentinvention, shown in FIGS. 2A and 3A;

FIG. 4A is a first perspective view of the in-line fat sampling deviceof the present invention;

FIG. 4B is a second perspective view of the in-line fat sampling deviceof the present invention;

FIG. 4C is a first exploded view of the in-line fat sampling device ofthe present invention, shown comprising a collection chamber, a lid withbarbed connector for connection to the suction tubing, a suction platehaving six projections for supporting six sample syringes, a selectorwith a passage from center to periphery to control flow of aspirated fatsample into the selected syringe, and a barbed connector for connectingto tubing extending to the hand-supportable fat aspiration instrument,and a spring pushing up the turning knob and keeping the selector at thebottom of the collection chamber;

FIG. 4D is a second exploded view of the in-line fat sampling device ofthe present invention,

FIG. 4E is a third exploded view of the in-line fat sampling device ofthe present invention;

FIG. 4F1 is a cross-sectional view of the in-line fat sampling device ofthe present invention shown in FIGS. 4A through 4E, illustrating thepassage within the selector component, extending from the center of thedevice to the periphery thereof to control the flow of aspirated fatsamples into the selected syringe;

FIG. 4F2 is a cross-sectional view of the in-line fat sampling deviceshown in 4F1, illustrating the flow of an aspirated fat sample from thepatient, through the fat aspiration instrument of the present invention,to the selector component of the fat sampling device, through thepassageway/flow director, into the selected syringe, whereupon fat cellsare collected within the selected syringe while excess fluid isexpressed through holes in the selected syringe, and passed out throughthe barded connector towards to vacuum source;

FIG. 4G is a graphical representation illustrating the process ofremoving collected visceral fat samples contained in syringes from thecollection container of the in-line fat sampling device of the presentinvention;

FIG. 4H is a perspective view of a syringe removed from the collectioncontainer of the in-line fat sampling device of the present invention,and arranged in proximity with a hole excluder and syringe plunger, foruse together when desiring to eject a visceral fat sample collected in aselected syringe within collection container of the in-line fat samplingdevice of the present invention;

FIGS. 4I1 and 4I2 set forth a graphical representation illustrating theprocess of using the hole exclude and syringe plunger to eject avisceral fat sample that has been collected in a syringe removed fromthe collection container of the in-line fat sampling device of thepresent invention;

FIG. 5A is a schematic diagram of the process illustrating the increasednegative feedback effect (i.e. decrease in fat burn) which an increasein hypertropic visceral fat cells have upon the basal metabolic rate(BMR) within a human being's metabolism, by the increased secretion ofLeptin, Resistin and TNF-α—prior to treatment according to theprinciples of the present invention;

FIG. 5B is a schematic diagram of the process illustrating a decreasedsecretion of Cytokines (i.e. Adipopectin) in response to an increase inhypertropic visceral fat cells, favoring a decrease in sensitivity ofperipheral tissues to insulin and thus a decrease in glucose utilizationthereby—prior to treatment according to the principles of the presentinvention;

FIG. 5C is a schematic diagram of a process illustrating a reduction inthe number of hypertropic fat cells and their harmful secretions (i.e.Leptin, Resistin and TNF-α) by the method of treatment according to thepresent invention, and the favorable impact on the patient's metabolismby increasing fat burn and the basal metabolic rate (BMR);

FIG. 5D is a schematic diagram of the process illustrating an increasedcirculation of secretion of Cytokines (i.e. Adipopectin) in response toa decrease in hypertropic visceral fat cells by practicing the method oftreatment according to the present invention, and the favorable increasein sensitivity of peripheral tissues to insulin and thus an increase inglucose utilization thereby;

FIGS. 6A and 6B a flow chart illustrating the primary steps carried outduring the illustrative embodiment of the method of treating obesity bymesenteric visceral fat aspiration according to the present invention,comprising diagnosis, exploration, partial omentectomy, small bowelmesenteric visceral fat aspiration, large bowel mesenteric visceral fataspiration, followed by subcutaneous visceral fat aspiration, abdominaland dermatolipectomies as indicated;

FIGS. 7A and 7B a flow chart illustrating the primary steps carried outduring the illustrative embodiment of the method of treating WHR andmetabolic syndrome by mesenteric visceral fat aspiration according tothe present invention, comprising diagnosis, exploration, partialomentectomy, small bowel mesenteric visceral fat aspiration, large bowelmesenteric visceral fat aspiration, followed by subcutaneous visceralfat aspiration, abdominal and dermatolipectomies as indicated;

FIGS. 8A and 8B a flow chart illustrating the primary steps carried outduring the illustrative embodiment of the method of treating type IIdiabetes by mesenteric visceral fat aspiration according to the presentinvention, comprising diagnosis, exploration, partial omentectomy, smallbowel mesenteric visceral fat aspiration, large bowel mesentericvisceral fat aspiration, followed by subcutaneous visceral fataspiration, abdominal and dermatolipectomies as indicated;

FIG. 9A is a perspective view of the patient's abdominal region duringthe first phase of a mesenteric visceral fat aspiration procedure of thepresent invention, showing the inspection of the small bowel and placinga region of proximal jejunum under tension between two graspers fortreatment, following creation of routine laparoscopy portals andcustomary CO2 infusion for abdominal distension;

FIG. 9B is perspective view of the patient's abdominal region during asecond phase of the mesenteric visceral fat aspiration procedure of thepresent invention, showing the insertion of a cannula into the mesenteryfor infusion of tumescent solution;

FIG. 9C is perspective view of the patient's abdominal region during athird phase of the mesenteric visceral fat aspiration procedure of thepresent invention, showing the insertion of the bipolarelectro-cauterizing twin-cannula visceral fat aspiration instrumentshown in FIG. 1, into the mesentery of the patient and fat removal byway of visceral fat aspiration under laparoscopy guidance with thelaparoscope shown;

FIG. 10 is a graphical illustration of the cross-section partially cutaway view of the patient's abdominal region during a later phase of themesenteric visceral fat aspiration procedure of the present invention,showing the aspiration and electro-cauterization of visceral fattytissue in the mesentery, using the laparoscopically-guided irrigatingbipolar electro-cauterizing twin-cannula visceral fat aspirationinstrumentation of the present invention; and

FIG. 11 is a graphical illustration of the abdominal region of apatient, showing areas where visceral fat is to be removed in the middle⅓ of the mesentery, while avoiding the major vessels at the root of themesentery near the aorta and the smaller direct supply vessels (vasarecti) near the bowel itself (i.e. where a great amount of visceral fatis located—in the fan-folded condensation of mesentery thickened withvisceral fat).

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS OF THE PRESENTINVENTION

Referring to the figures in the accompanying Drawings, the variousillustrative embodiments of the present invention will be described ingreat detail, wherein like elements will be indicated using likereference numerals.

Overview On Methods Of Treatment According To Principles Of The PresentInvention

In general, the method of treatment according to the present inventioninvolves performing vacuum-assisted aspiration of mesenteric fat from apatient in the intra-abdominal region, using either an “opendirect-viewing” based laparotomy procedure, or preferably, aminimally-invasive, “laparoscopic” based procedure using the new andimproved fat aspiration instruments of the present invention.

The open direct-viewing based procedure involves a surgical team makinga direct laparotomy incision into the abdomen of the patient using theirown direct human vision to guide their surgical instruments, whileperforming a visceral fat aspiration procedure/method in accordance withthe principles of the present invention.

The laparoscopic-based procedure involves a surgical team making one ormore limited access portals into the patient's abdomen and usinglaparoscopic and/or camera monitor assistance for their human vision,while performing the visceral fat aspiration procedure/method in aminimally invasive fashion according to the principles of the presentinvention.

Using either method, visceral fat is safely removed from the mesentericregion of a patient to help to ameliorate the metabolic syndrome,abdominal obesity and/or type II diabetes.

Specification Of The Laparoscopically-Guided Intra-Abdominal VisceralFat Aspiration Instrument System Of The Present Invention, Designed ForSafely Removing Visceral Fat From The Mesenteric Region Of A Patient

In FIG. 1A, there is shown a preferred laparoscopically-guidedintra-abdominal visceral fat aspiration instrument system 1 forperforming the mesenteric visceral fat aspiration methods of the presentinvention, typically in an operating room environment. The system 1comprises: an endoscopy (e.g. laparoscopy) subsystem, or laparoscope 2having (i) a video probe 2A provided with an embedded 2D high-resolutiondigital color image sensor with a field of view (FOV) for insertion intothe abdomen of the patient 3, (ii) one or more video monitors (e.g. LCDdisplays and controller) 2B for displaying to surgeons and assistants,real-time digital color video images of the patient's abdominal regioncaptured along the field of view (FOV) of the video probe 2A, and (iii)digital recording equipment 2C for recording captured digital videoduring the operation and marking the same by the surgeons, as required;a bipolar electro-cauterizing twin-cannula powered visceral fataspiration system 4 having (i) a powered hand-supportable fat aspirationinstrument 4A provided with a self-irrigating, bipolarelectro-cauterizing and fiber-illuminating twin-cannula assembly 5, (ii)a system controller 4B connected to the hand-supportable instrument 4Aby way of a flexible multi-lumen cable assembly 4C, for supplying (i)pressurized air streams 6 from pressurized gas source 6A to drive theinner cannula of the hand-supportable instrument 4A (shown in FIGS. 2Athrough 2H), or (ii) electrical power signals 6′ from electrical powersource 6B to drive hand-supportable instrument 4A′ (shown in FIGS. 3through 31), and optionally (iii) RF-power signals 7 generated by an RFsignal generating module 4D for powering the self-irrigating bipolarelectro-cauterizing and illuminating twin cannula assembly 5, as taughtin U.S. Pat. No. 7,384,417 B2; a vacuum pump 4E operably connected tothe inner cannula via a flexible tubing and other components, foraspirating visceral fat through the aspiration aperture 9 of the twincannula assembly 5 during system operation; an infusion pump 4Fcontrolled by the system controller 4B, for periodically or continuouslypumping irrigation fluid through irrigation tube 12 and into anirrigation port on the cannula assembly for infusing solution near thedistal portion of the cannula assembly 5 during system operation; anoperating table 11 for supporting a patient; a multi-spectralillumination source 4G providing the surgeon with selectable spectrumcontrol, to deliver a desired spectrum of illumination along an opticalfiber 12 to the outer cannula and produce a field of illuminationspatially-overlapping the field of aspiration about the reciprocatinginner aspiration aperture 9 at the distal portion of the twin-cannulaassembly 9; in-line fat sampling device 14 installed in-line along theflexible tubing 9A, 9B, for collecting and indexing samples of visceralfat while the surgeon samples the abdominal region of the patient, forsubsequent analysis and testing/measurement for compounds indicative ofobesity, metabolic syndrome and/or type II diabetes; and other operatingroom equipment including high intensity lighting apparatus, retractionclips, stitches etc.

In addition, the laparoscopically-guided visceral fat aspiration system1 of the present invention further includes instruments such as trocarsfor penetrating the abdomen, laparoscopic graspers, laparoscopicscissors, and a CO2 infusion tube (supplied from CO2 gas source 6A), asdescribed in detail in U.S. Pat. No. 7,384,417 B2, incorporated hereinby reference.

Typically, infusion pump 4F will include a roller pump which compressesthe tubing to create forward flow, as disclosed in U.S. Pat. No.7,384,417 B2 incorporated herein by reference. The infusion pump 4Fsupplies a pulsatile flow of irrigation fluid through the distal tipportion of the twin-cannula assembly of the present invention, as shownin FIGS. 2D 3 and 2D4, so that controlled amounts of fluid are deliveredunder short periods of time to facilitate synchronization with eitherthe forward or return stroke of the inner cannula 5B. This feature willbe described in great detail hereinafter.

In the illustrative embodiment of the present invention, themulti-spectral illumination source 4G can be constructed from a whitelight source producing a white light beam that is filtered by aselectable color filter wheel, with associated optics, interfaced with afiber-optic delivery cable, to provide the surgeon with selectablespectrum control, to deliver a desired spectrum of illumination (e.g.red, blue and/or yellow) at and about the aspiration aperture of the fataspiration instrument 4A. Alternatively, the illumination source 4G canbe realized using a multi-spectral LED array with associated optics,interfaced with a fiber-optic delivery cable, to provide the surgeonwith selectable spectrum control, to deliver a desired spectrum ofillumination (e.g. red, blue and/or yellow) at and about the aspirationaperture of the fat aspiration instrument 4A. The multi-spectralillumination source 4G can also be adapted to generate and deliver abright red light beam at the time of, and at the location of visceralfat aspiration about the distal portion of the twin-cannula assembly 5.Also, in addition to white-type light being supplied by the laparoscopiclight source during operations, the multi-spectral illumination source4G can supply red/blue/yellow light (i.e. illumination) through thefiber-optic channel along the twin-cannula assembly, to illuminatetissue about the aspiration aperture, to help visually distinguish andaccentuate arterial vessels, veins and fat itself, and facilitatevesiculations of arterial blood vessels, portal and systemic veins, andfat. In yet alternative embodiments, the color wheel may be rotatedcontinuously, offering a 3-D emphasis of the treatment area.

In FIGS. 2A through 2G, a hand-supportable multi-function visceral fataspiration instrument 4A is shown for use with system 1 depicted in FIG.1A. This embodiment of the instrument of the present invention ispowered by a source of pressured air or gas (e.g. a pressurized-aircylinder driven by source of pressurized gas (e.g. CO2)). In FIGS. 3Athrough 3J, an alternative embodiment of the hand-supportablemulti-function visceral fat aspiration instrument 4A′ is shown for usewith system 1 depicted in FIG. 1A. This alternative embodiment of theinstrument is powered by an electromagnetic motor driven by electricalcurrent delivered through coil windings at a given voltage. Bothinstruments 4A and 4A′ employ the multi-function twin-cannula assembly 5of the present invention shown in FIGS. 2C through 2D4, and supportingits multiple functions, namely: bipolar electro-cauterization, fluidirrigation, and spectrum-controlled illumination at and about thereciprocating aspiration aperture 9 of the twin-cannula assembly.

In FIGS. 4 through 412, an in-line visceral fat sampling device 14 foruse with the fat aspiration instruments of the present invention, isdescribed in technical detail. This in-line fat sampling device allowsthe surgeon to easily collect and index samples of visceral fataspirated in particular regions of the patient's abdominal cavity, forsubsequent analysis that may be informative during subsequent serial fataspiration procedures during a particular course of treatment.

It is appropriate at this junction, to now describe in greater detailthe coaxially-driven multi-function visceral fat aspiration instruments4A and 4B of the present invention.

Specification Of The First Illustrative Embodiment Of The Twin-CannulaMulti-Function Co-Axially Driven Visceral Fat Aspiration Instrument OfThe Present Invention

In FIG. 2A, the first illustrative embodiment of the twin-cannulavisceral fat aspiration instrumentation system 1 is shown comprising: ahand-supportable fat aspiration instrument 4A having (i) ahand-supportable housing 15 with a stationary tubing connector 16provided at the rear of the housing and receiving a length of flexibletubing 9A connected to a vacuum source 4E and connecting to thecylindrical cannula base portion guide tube 20, and (ii) amulti-function twin-cannula assembly 5 having an inner cannula 5B withan inner cannula base portion 20 disposed within the cylindrical cannulabase portion guide tube 21, and coupled to an pneumatically-poweredcannula drive mechanism (as illustrated in FIG. 2A2) housed within thehand-supportable housing and powered by a source of pressurized air orother gas, while its stationary outer cannula 5A is releasably connectedto the front portion of the hand-supportable housing 14; systemcontroller 4B for controlling the electro-cautery, irrigation andillumination functions supported by the fat aspiration instrument; anaspiration source 4E; a pneumatic power source 6A; and a flexiblemulti-core cable assembly 20 connecting the system controller 4B and thehand-supportable instrument 4A; and an infusion pump 4F for supplyingirrigation fluid to an infusion port 35 on the outer cannula viaflexible tubing, and connected to the system controller 4B forsynchronized pulse control, and operational to synchronize the releaseof irrigation fluid (i.e. infusion) with inner cannula motion.

As shown in FIG. 2A, the air-powered fat aspiration instrument 4Acomprises a single-button quick connect plug 22 provided on the rearportion of the hand-supportable housing, for connecting the multi-corecable assembly 23 and supporting two gas lines and three electric wiresbetween the instrument and the system controller in a single bundle, astaught in U.S. Pat. No. 7,381,206 to Cucin, incorporated herein byreference, with appropriate modifications for the application at hand.While RF power signals can also be supplied through the multi-core cableassembly, and routed as necessary to the cautery leads 30A and 30Bprovided on the outer cannula base portion, as shown in FIGS. 2A and2A1, RF power signals can be supplied through power cables 31 that areseparate from the multi-core cable assembly 23.

As shown in FIGS. 2B and 2C, the twin-cannula assembly 5 comprises aninner cannula component 5B that is slidably received within an outercannula component 5A. The inner cannula component 5B has a distal endand a proximal end and an inner aspiration aperture 8, and is providedwith a Leur-lock fitting 25 at its proximal end so as to be able toconnect to a matched fitting provided on the inner cannula base portion20 which reciprocates within the cylindrical cannula base portion guidetube 21, mounted within the hand-supportable housing 15. The outercannula component 5A also has a distal end and a proximal end and anelongated outer aspiration aperture 9, and is provided with a Leur-lockfitting 26 at its proximal end so as to be able to connect to a matchedfitting provided on the outer cannula base portion 5C which connects tothe front portion of the housing 15 by way of a threaded hole formedtherein as shown in FIG. 2A2. The inner and outer cannulas are keyed toensure that the inner aspiration aperture 8 is always in registration(i.e. cannot rotate within the outer cannula, and remains in constantalignment) with the elongated aspiration aperture (i.e. slot) duringinstrument operation.

The outer cannula component 5A is shown detailed in FIGS. 2D1 through2D4, the outer cannula base portion 5C is detailed in FIGS. 2E1 through2E5, and the inner cannula component 5B is detailed in FIGS. 2A2 and 2B.When fully assembled, and configured with its hand-supportableinstrument housing, and the other components of the system 1, thetwin-cannula assembly 5 of the present invention simultaneously performsa number of important functions during visceral fat aspirationoperations, namely: tumescent infusion of an irrigation fluid,electro-cauterization of aspirated fat passing through the inneraspiration aperture 9, and variable-spectrum fiber-illuminationdelivered across the field of irrigation, about the outer aspirationaperture 9. These functions will be described in greater detailhereinafter.

As shown in FIGS. 2D1 and 2D2, the outer cannula component 5A isrealized as a thin tube made from stainless steel tubing (No. 304) andthen coated with a white-colored PFA (Dupont Teflon®) coating. Also, theinner cannula component 5B is realized as a thin tube (of slightlysmaller outer diameter dimensions than the outer cannula) made fromstainless steel tubing (No. 304) and then coated with a black-coloredPFA (Dupont Teflon®) coating. These high contrast coatings will serve torender the moving “white” (reflective and bright) inner cannulaaspiration aperture 9 highly visible against the “black” (absorptive anddark) outer cannula, in digital video images captured, buffered anddisplayed (in real-time) during video-guided fat aspiration operationscarried out in accordance with the principles of the present invention.While PFA coatings are applied over the outer surfaces of the inner andouter cannulas, PFA coating material should be removed from theperipheral edges of the outer cannula aspiration aperture 8 and theinner cannula aspiration aperture 9 where electrical field potentialsare to be generated during bipolar electro-cauterization operationsabout the relatively moving outer aspiration apertures. Also, PFAcoating material should be removed from the outer surface of theproximal portion of the inner cannula so that electrical contact can beestablished between the radially extending contacts (brushes) 30supported within the non-conducting outer cannula base portion 5C, shownin FIGS. 2E2 and 2E3, and electrically connected to the bipolar RFsignal supply port 30A provided on the exterior of the outer cannulabase portion 5C.

As shown in FIGS. 2D1 through 2D4, an irrigation supply port 31 isprovided on the proximal end of the outer cannula before its Leur-lockfitting, and an irrigation channel 32 is formed along the wall of theouter cannula component (via longitudinal brazing) and terminates at anirrigation release port 33 located at the distal tip portion of thecannula, for suppling irrigation fluid on the inside of thebullet-shaped distal portion of the outer cannula, adjacent its outeraspiration aperture/slot 8, as clearly shown in FIGS. 2D3 and 2D4, toprovide continuity with the interior of the outer cannula at the tip tomaximize sump effects and directed irrigation.

By delivering the irrigation fluid into the very tip of the insideregion of outer cannula the following benefits are achieved: (1) maximalsump effect to help aspiration of fat; and (2) hydrostatic dissectionevery time the inner cannula advances and push the irrigation solutionthat has collected inside the outer cannula between the back-strokedinner cannula and the dome of the outer cannula into the tissues(mesentery) to facilitate dissection. Tumescent solution may beemployed, e.g. lactated Ringers and a very dilute solution ofepinephrine may be employed to minimize bleeding.

On the opposite side of the outer cannula component, a fiber opticsupply port 35 is an integrated fiber-optic port is provided on theproximal end of the outer cannula before its Leur-lock fitting 30B, anda fiber optic channel 36 is formed along the wall of the outer cannulacomponent (via longitudinal brazing) and terminates at an illuminationport 37 located at the distal tip portion of the cannula. An opticalfiber 38 is installed through the fiber optic supply port 35 and alongthe fiber channel 36, and provided with a conventional fiber optic cableconnector at the fiber optic supply port 35, so as to supply anillumination signal that is delivered to the illumination port 37 toilluminate tissue in the region outer aspiration aperture 8 of the outercannula 5A during fat imaging and aspiration operations. Notably, theend of the optical fiber will be shaped appropriately at theillumination port 37 to provide a field of illumination that spatiallyoverlaps the field of aspiration about the outer aspiration aperture, toensure that tissue within and about the field of aspiration is optimallyilluminated while digital video images of the distal portion of thetwin-cannula assembly 5 are being captured, buffered and display onvideo display units mounted in the operating room, for the surgeon toview and use while manually guiding the distal portion of the cannulawithin the patient's abdominal region during surgery, to remove visceralfat in the patient's mesentery region.

In order to supply bipolar RF signals to the electrically conductiveinner and outer cannula component of the twin-cannula assembly of FIG.2D1, the non-conductive outer cannula base portion 5C is provided withfirst RF power signal port 30A to which a first RF signal cable isconnected in a conventional manner, whereas the electrically conductiveouter cannula is provided with second RF power signal port 30B to whicha second RF signal cable is connected in a conventional manner. A firstelectrical connection is established between the RF power signal port30B and the electrically-conductive outer cannula tubing 5B, which maybe realize using electrical wiring and soldering in a manner known inthe art, or other techniques known in the art. Also, a second electricalconnection is established between the RF power signal port 30A and thearray of radially-projecting electrical contacts (i.e. brushes) 30mounted within the inside bore of the outer cannula base portion 5C, asshown in FIG. 2E4 and 2E5. The second electrical connection may also berealized using electrical wiring and soldering in a manner known in theart, but other techniques may be used as well.

During twin-cannula operation, the set of radially arranged electricalcontacts 30 establish low-friction electrical contact with the exposednon-coated portion of the outer surface of the electrically conductiveinner cannula 5B. With this arrangement, a first polarity of thesupplied RF power signal is conducted to the electrode region 32B formedabout the peripheral edge of the inner cannula aspiration aperture 8,while the second polarity of the RF power signal is conducted to theelectrode region 32A formed about the peripheral edge of the outercannula aspiration aperture 5A, to thereby provide bipolarelectro-cauterization about the moving inner aspiration aperture, withinthe fields of aspiration, irrigation and illumination.

As shown in FIG. 2A2, the reciprocating inner cannula 5B has luer lockfitting 25 to mate to luer lock fitting 25′ on the inner cannula baseportion 20; magnet 48 is affixed to inner cannula base portion 20 usinga screw-on nut 45; front and rear gas tubes 57 and 58 run to from thefront of the housing to the rear multi-core quick connect plug 22; thequick connect multi-core plug 22 connects to multi-core cable containingtwo fluidic (gas) channels and at least three low voltage electricalcircuits; the cable 23 runs to controller 4B within which the gaschannels directly attached to the compressed gas source (not shown); thefront and rear Hall sensors 22 and 23 are provided within thehand-supportable housing, for detecting the excursion of the cannulabase portion 20 within the cylindrical guide tube 1; front and rear flatsealing washers 46 and 47 are provided for slidably supporting the innercannula base portion 20 along the cylindrical guide tube 21; threadedchamber cover 10 is provided with a hole, through which the innercannula 5B protrudes; sufficiently large through-and-through vents areformed in the threaded chamber cover 10 to allow any gas that leaks pastthe front washer 46, to exit the chamber. Such air venting to theambient is less critical because the concentric tube-with-a-tubestructure, and the sliding of the cannula base portion 20 inside therear tubing connector assembly, provides effective seals in and ofthemselves. Also, in this embodiment, the walls of at least the front(pneumatic) chamber portion of housing should be made from anon-magnetizable metal (e.g. SS 304) or other material that will supportthe necessary gas pressure of actuation (e.g. ˜100 PSI).

During instrument operation, the Hall effect sensors 52 and 53 sense theposition of the inner cannula base portion 20 within cylindrical guidetube 21 by sensing the magnetic field of its magnetic ring 8. As theinner cannula base portion 20 reciprocates within the cylindrical guidetube 21, the aspiration/vacuum tubing 9A connected to the barb connector16 on the stationary tubing connector, remains stationary and therebypreventing any jerking action on the surgeon's hands and reducing imagejitter during video image capture and display operations. Also, theinner and outer cannulas 5A, 5B are provided with luer-lock fittings 25,26 respectively, while the inner cannula base portion 20 is typicallyrealized or provided as a sterile single-use disposable item, made fromplastic or metal, and having a low cost magnet and silicone washers toprovide fluid seals between the inner cannula base portion 20 and thecylindrical guide tube 21 within the hand-supportable housing 15.

In FIG. 2F, the system controller 4B is shown comprising a number ofcomponents, namely: an analog-to-digital converter (ADC) receivingsignals generated by the front and rear Hall-effect cannula baseposition sensors installed within the hand-supportable housing of theinstrument; a LCD panel; communication ports; LED indicators; and panelmembrane switches supported on the controller console housing; digitalsignal processor (DSP); and a digital-to-analog converter (DAC) andproportional valve contained within the controller console housing, andsupplying gas tubes (via the multi-core cable assembly); and ports forreceiving a supply of pressurized gas, for controlled supply to theinner cannula drive mechanism of this embodiment of the presentinvention. For further details on constructing a system controller, suchas system controller 4B, reference should be made to U.S. Pat. No.7,381,206 to Cucin, incorporated herein by reference.

The flow chart of FIG. 2G describes the operation of the infusion pump4F in cooperation with irrigating electro-cauterizing visceral fataspiration instrument illustrated in FIGS. 2A through 2E. The cauterycontrol program written set forth in FIG. 2H describes when to open andclose the cautery relay switch employed within the electro-cautery RFpower signal generation module of the system controller. Such controloperations are carried out by the DSP in the system controller. Acontrol program is also provided within the DSP for activating theillumination source when the twin-cannula assembly is being driven byits integrated pneumatic motor.

During system operation, the inner cannula base portion 20 reciprocateswithin the cylindrical guide tube 21, while the aspiration/vacuum tubing9A connected to the barb connector 16 on the stationary tubingconnector, remains stationary and thereby preventing jerking action onthe surgeon's hands and reducing image jitter and blurring during videocapture and display operations during surgery. Also, the infusion pump4F delivers controlled amounts of fluid through the irrigation channel32 and out the irrigation port 33, over short periods of time, insynchronization with either the forward or return stroke of the innercannula 5B within the outer cannula 5A. Such irrigation facilitatesfluid flows out of the irrigation aperture 33 and proximate to theelongated aperture 8, while visceral fat is being electro-cauterized byelectrodes 32A, 32B and aspirated through the reciprocating aspirationaperture 9 of the hand-supportable visceral fat aspiration instrument.At the same time, the fiber optic supply port 35 and fiber deliverychannel 36 illuminates tissue within the field of aspiration, while ahigh resolution digital imager 2A with a field of view (FOV) on thedistal portion of the twin-cannula assembly captures high contrastimages of the white (reflective) and black (absorptive) coloredPFA-coatings on the outer and inner cannulas 5A and 5B respectively, toassist the surgeon in practicing the method of the present invention.

FIG. 2C describes the primary control operations performed by systemcontroller 4B during fluid irrigation delivery operations using thesurgical system of FIG. 1. Specifically, as indicated at Step A in FIG.2C, the inner cannula 5B is driven to reciprocate within the outercannula 5A while the hand-supportable visceral fat aspiration instrumentis being used during a laparoscopically-guided mesenteric visceral fataspiration operation on an obese patient, wherein visceral fatty tissueis aspirated through its moving aspiration aperture. As indicated atStep B, when the inner cannula is displaced at its maximal strokeposition within the outer cannula, irrigation fluid is automaticallypulsed through the irrigation channel/lumen integrated within the outercannula, so that irrigation fluid is expressed out of the irrigationaperture, proximate to the outer aspiration aperture, and into theregion where visceral tissue is being aspirated within the mesentery ofthe patient. As indicated at Step C, the automatic pulsing of irrigationfluid through the irrigation aperture is ceased when the inner aperturemoves away from its maximal stroke position and towards its minimalstroke position. As indicated at Step D, the operations of Steps B and Care repeated while driving the inner cannula to reciprocate within theouter cannula. The control routine of FIG. 2F will be realized usingcomputer programming techniques well known in the art.

Specification Of The Second Illustrative Embodiment Of The Twin-CannulaMulti-Function Co-Axially Driven Visceral Fat Aspiration Instrument OfThe Present Invention

In FIG. 3, the second illustrative embodiment of the multi-functiontwin-cannula visceral fat aspiration instrument 4A′ is shown for use inthe system 1 of FIG. 1. As shown, this visceral fat aspirationinstrument 4A′ comprises: a hand-supportable housing 15 with astationary tubing connector provided at the rear of the housing andreceiving a length of flexible tubing 9 connected to vacuum source 4Eand connecting to the cylindrical cannula base portion guide tube 50,and (ii) the twin tumescent-type cannula assembly 5 employed in thefirst illustrative embodiment 4A (FIGS. 2D1 through 2E5) having an innercannula 5B coupled to an electrically-powered cannula drive mechanismdisposed within the hand-supportable housing and powered by a source ofelectrical power, while its stationary outer cannula 5B is releasablyconnected to the front portion of the hand supportable housing; (ii) asystem controller 4B′ for controlling the electro-cautery, irrigationand illumination functions supported by the fat aspiration instrument4A′ of the present invention.

FIGS. 3D1 through 3D8 show how the components of the visceral fataspiration instrument of the present invention are assembled, in astep-wise manner.

As shown in FIG. 3E, the hand-supportable visceral fat aspirationinstrument 4A′ comprises: a cylindrical guide tube 1 mounted within thehand-supportable housing 2, and the (disposable) inner cannula baseportion 50 carries a permanent magnetic ring 58 between a set of fluidseals 56 and 7 that slidably support the cannula base portion 60 withinthe cylindrical guide tube 50. The inner cannula 5B is coupled to thecannula base portion 60 by way of a mated luer-lock coupling 25, 25′ andthe lumen extending within the cannula and its inner cannula baseportion 60 is in fluid communication with the stationary tubingconnector 16, by way of the interior volume of the cylindrical guidetube 50 between the cannula base portion 60 and the stationary tubingconnector 16. The stationary tubing connector 16 (having a barbed tubingconnector portion) is adapted to unscrew from the rear portion of thehand-supportable housing so that housing back plate 59 can be removed sothat the cylindrical guide tube 50 (i.e. the wound bobbin) can be slidinto the hand-supportable housing 15. The top and bottom of the hollowcylindrical ring magnet 58 produce opposing magnetic poles, and magnet58 is secured onto the inner cannula base portion 60 and against flange54 by way of nut 55 which screws onto a set of threads form on othersurface of the cannula base portion 60. In the illustrative embodiment,the fluid seals 56, 57 are realized as a pair of thin-walled,collapsible (i.e. invertible) bell-shaped silicone sealing washers whichact as front and rear diaphragms allowing motion of the cannula baseportion within the cylindrical guide tube. By setting mid-pointgeometry, one washer can effect a return stroke without need of coilpolarity reversal, simply pulsing sufficing. Mounted about outer surfaceof the cylindrical guide tube, front and rear coil windings 61 and 62are formed, respectively, and electrically connected to the connectorplug 64 formed on the rear end of the hand-supportable housing.

FIG. 3D2 clearly reveals the components of the instrument 4A′ ascomprising: cylindrical guide tube 50 with flanges for containingelectromagnetic coil windings (61, 62); hand-supportable housing 15;housing back plate 59; stationary tubing connector 16 with a vacuumtubing barb; flange 54 on inner cannula base portion 60; magnetfastening nut 55; front washer 56; back washer 57; ring magnet 58; innercannula 5B provided with a luer-lock fastener 25; front chamber screwcap 10; back electromagnetic coil 61; front electromagnetic coil 62;disposable inner cannula base portion 60 provided with as luer-lockfastener 25′; and contact/connector plug 59 (e.g. Binder 719).

FIGS. 3D1 through 3D8 show how these components are assembled in steporder fashion, in a front-loading manner, and the twin-cannula assembly5 is simply connected to the (disposable) inner cannula base portion 60,using luer-lock coupling mechanisms 25, 25′ well known in the art, tocompletely assemble the instrument and prepare it for use in surgery.

Taken together, FIGS. 3F1 through 3F4 shows how the first and secondelectromagnetic coils 61, 62 are wound about the cylindrical guide tube50, and then how wiring of these coils are electrically connected to theelectrical connector mounted on the housing back plate 59, employed inthe first illustrative embodiment shown in FIGS. 2A through 5E. FIG. 3F5shows a schematic diagram depicting how the two coil 61 and 62 aredriven by a push-pull type of circuit, for the purpose of enabling theinner cannula drive mechanism employed in the hand-supportable fataspiration instrument 4A′ illustrated in FIG. 3A.

Third Illustrative Embodiment Of The Visceral Fat Aspiration InstrumentSystem Of The Present Invention

In FIG. 3G1, an alternative embodiment of the hand-supportable fataspiration instrument of FIG. 3A, depicted as 4A″ is shown, comprising:a cylindrical (inner cannula base portion) guide tube 50″ adapted tosupport three electromagnetic coils, rather than two coils used in thefirst illustrative embodiment 4A′, for the purpose of implementing theinner cannula drive mechanism employed in the fat aspiration instrument.FIG. 3G2 shows a schematic diagram for this three coil push-pull type ofcircuit, driven by a 1-30 HS AC electrical signal, for enabling theinner cannula drive mechanism employed in the alternative embodiment ofthe hand-supportable fat aspiration instrument 4A″ in FIG. 6A. In allother respects, the fat aspiration instrument of the third illustrativeembodiment 4A″ is like the fat aspiration instrument 4A′.

Specification Of The In-Line Visceral Fat Sampling Device Of The PresentInvention

Referring to FIGS. 4 through 412, the in-line fat sampling device 14 ofthe present invention will now be described.

As shown in FIGS. 4C through 4E, the in-line fat sampling device 14comprises: a optically-transparent collection chamber 70 having closedend 71 with a central aperture 72, and an open end 72 with hollow innerchamber/space disposed between the closed end 71 and the open end 73; aremovable lid 74 for threaded connection to the open end of thecollection chamber, and having a central flow channel 75 terminated in afirst barbed connector 76 for connecting the device to vacuum source 4Eby way of a section of flexible vacuum tubing 9B; a stationary suctionplate 77 having six hollow projections 78A through 78H for supportingthe open ends of six sample syringes 80A through 80H, each havingperforations 81 in the walls thereof (to allow fluid to flowtherethrough while in the collection chamber) and being keyed forregistration with the collection chamber (to prevent rotation); arotatable selector 82 (shown in FIG. 4F1) for rotational engagement withthe suction plate 77 and having a hollow central post section 82A thatpasses through central aperture 72 and establishes fluid communicationwith a passage/conduit 82B that extends from center of the to peripheryto control the flow of aspirated fat sample from the instrument 4A, 4A′,4A″ through the first section of tubing 9A, through the selector 82 andinto the selected syringe/projection 80 combination; a turning knob 84mounted on and engaging with the hollow selector post 82A and enablingthe turning of the rotatable selector 82 relative to the stationarysuction plate 77 to select the syringe/projection combination into whichan aspirated fat sample should flow for collection and indexing purposesduring surgery; a spring 85 mounted between the turning knob 84 andhollow selector post 82A to push up the turning knob and keeping theselector 82 at the bottom of the collection chamber; and a second barbedconnector 86 connected by threads to the hollow selector post 82Aallowing the fat sampling device 14 to be connected to the fataspiration instrument 4A, 4A′ by way of a second section of flexiblevacuum tubing 9B.

Surgeon installs the fat sampling device 14 inline between the fataspiration instrument 4A, 4A′ and the vacuum source 4E as shown in FIG.4A. The collection chamber 70 is labeled for orientation, indicating theside to patient and the side to vacuum source. The turning knob 84 hasan arrow on it. The suction plate 77 has numbers 1-6 for each of thestoppered perforated syringe barrels 80A-80H connected to it. Thesurgeon then pushes down on turning knob 84 against the biasing force ofspring 85 and that pushes the selector slightly forward so the knob canbe turned to select which syringe to collect to, until it is full,counting from 1 to six. The selector 82 has a detente dome extrusionwhich fits into the corresponding dimple below the selected syringe. Thespring 85 maintains the selector 82 in its selected position. As shownin FIG. 4E and 4F1, suction plate 77 has two flanges 87A and 87B whichsnap over the selector 82, and grip a groove that runs around it tosecure it in place relative to the selector 82.

When practicing the method of treatment according to the presentinvention, the surgeon initially performs sampling of visceral fat inthe SB mesentery of the small bowel, starting at the duodenum, thebeginning, middle and distal jejunum and the ileum before returning tothe proximal jejunum to begin the first defatting treatment, with thecirculating nurse noting into which syringe the aspirated fat from eacharea is being collected. When all syringes are full of fat, unit isdisconnected and vacuum source is connected directly to the hand piece.The fat sampling device may be replaced with another one for sampling atshorter distances if desired.

As shown in FIG. 4F2, during fat aspiration operation using the systemof the present invention, an aspirated fat sample flows from theabdominal region of the patient, through the fat aspiration instrumentof the present invention, through tubing 9A and the hollow selector post82A, through passageway/flow director 82B, into the selected collectionsyringe 80A-80H supported on the stationary suction plate 77 and cappedwith cap portion 80A-80H, respectively. Fat cells are collected withinthe selected syringe while excess fluid is expressed through holes inthe selected syringe, and passed out through the barded connector 76towards to vacuum source 4E.

FIG. 4G shows a process of removing collected visceral fat samplescontained in syringes in the in-line fat sampling device of the presentinvention. This involves removing the lid portion 74, and withdrawingthe syringes supported on the suction plate assembly 77. Then as shownin FIGS. 4H and 41, a capped fat containing syringe 80A is removed fromthe suction plate 77 and snapped into an syringe hole occluder 90 androtated to as to occlude the holes/perforations 81 formed in the wallsof the syringe, as shown in FIG. 4A1. Then a plunger 91 is inserted intothe syringe, and the indexed fat sample is expressed out for testing andanalysis purposes, typically in one or more of the laboratory methodsdescribed below.

In general, the kind of tests/measurements to be performed on a visceralfat sample will depend on the condition being treated. However, it wouldbe helpful to measure concentrations of a particular aspirated fatregion, using the following laboratory methods: measure resistin levelsusing the Resistin human ELISA kit (VinciBiochem, Vinci-FI, Italy];determine adiponectin levels using a radioimmunoassay method [LincoResearch, St. Charles, Mo., USA; and quantify TNF-a, interleukin-6(IL-6), and IL-10 using an enzyme-linked immunoassay (ELISA) method[BioSource Cytoscreen, ELISA UltraSensitive Kits, Camarillo, USA].

Subsequent serial defattings will target the region showing the highest(measured) levels of leptin, and resistin, TNF-alpha, and Interleukin 6(IL-6) and lowest levels of adipopectin. IL-6 is anti-inflammatorymarkers associated with increased risk of coronary artery disease andinsulin resistance.

The Science Underlying The Methods Of Treatment According To The PresentInvention

The science underlying the visceral fat aspiration based methods of thepresent invention is represented in the schematic illustrations setforth in FIGS. 5A through 5D.

FIG. 5A illustrates the increased negative feedback effect (i.e.decrease in fat burn) which an increase in hypertropic visceral fatcells have upon the basal metabolic rate (BMR) within a human being'smetabolism, by the increased secretion of Leptin, Resistin andTNF-α—i.e. prior to treatment according to the principles of the presentinvention.

FIG. 5B illustrates a decreased secretion of Cytokines (i.e.Adipopectin) in response to an increase in hypertropic visceral fatcells, favoring a decrease in sensitivity of peripheral tissues toinsulin and thus a decrease in glucose utilization thereby—i.e. prior totreatment according to the principles of the present invention.

FIG. 5C illustrates a process caused by reducing the number ofhypertropic fat cells and their harmful secretions (i.e. Leptin,Resistin and TNF-α) by the method of treatment according to the presentinvention, and the favorable impact on the patient's metabolism byincreasing fat burn and the basal metabolic rate (BMR).

FIG. 5D illustrates a process of increased circulation of secretion ofCytokines (i.e. Adipopectin) in response to a decrease in hypertropicvisceral fat cells by practicing the method of treatment according tothe present invention, and the favorable increase in sensitivity ofperipheral tissues to insulin and thus an increase in glucoseutilization thereby.

In FIG. 10, a cross-sectional view of the patient's abdominal region isprovided during a later phase of the mesenteric visceral fat aspirationprocedure of the present invention, showing the aspiration andelectro-cauterization of visceral fatty tissue in the mesentery, usingthe laparoscopically-guided irrigating bipolar electro-cauterizingtwin-cannula visceral fat aspiration instrumentation of the presentinvention.

FIG. 11 shows areas where visceral fat is to be removed in the middle ⅓of the mesentery—i.e. avoiding the major vessels at the root of themesentery near the aorta and avoiding the smaller direct supply vessels(vasa recti) near the bowel itself i.e. where most the fat is anyway—inthe fan-folded condensation of mesentery thickened with visceral fat.

Method of Treating Obesity According To The Principles of the PresentInvention

FIGS. 6A and 6B illustrate the primary steps carried out when practicingthe method of treating morbid obesity by mesenteric visceral fataspiration according to the illustrative embodiment of the presentinvention, comprising the steps: diagnosis, exploration, partialomentectomy, small bowel mesenteric visceral fat aspiration, large bowelmesenteric visceral fat aspiration, followed by subcutaneous visceralfat aspiration, abdominal and dermatolipectomies as indicated.Preferably, the fat aspiration operations indicated above are carriedout using the apparatus described in FIGS. 1 through 4I2, although it isunderstood that other techniques and apparatus can be used.

As indicated in Step A in FIG. 6A, the surgeon diagnoses a patient withmetabolic syndrome and/or obesity (morbid obesity) using thewaist-to-hip ratio (WHR) and by physical measurements and lab tests.Morbid Obesity is defined as being 100 lbs over the ideal body weight orhaving a Body Mass Index (BMI) greater than or equal to 40.

As indicated in Step B in FIG. 6A, the surgeon performs a briefabdominal exploration or inspection to eliminate the presence ofinflammatory bowel disease and other contraindications to surgery, suchas, diverticulitis and a Meckel's diverticulum, or any other pathology.At her option, the surgeon may infuse a tumescent solution (Ringer'slactate with or without dilute epinephrine, and with or withoutxylocaine) as described above to prepare the area for treatment.

As indicated in Step C in FIG. 6A, the surgeon performs a partialomentectomy by removing the redundant omental apron.

As indicated in Step D in FIG. 6A, when performed as an opendirect-viewing procedure, the omentum is retracted and the jejunum isexposed. Either by the hands of an assistant in an open procedure orwith aid of atraumatic laparoscopic graspers [Endo Babcock or DolphinNose Grasper], the proximal jejunum is isolated and placed under gentletension. One atraumatic grasper is inserted in the right upper quadrantfor retraction of the jejunum towards the liver, and a second atraumaticgrasper is inserted in the left lower quadrant, placed on a section ofjejunum approximately 6 to 8 inches distal to the previously placedgrasper, and retracted caudally towards the left lower quadrant. Thejejunum is placed under tension and the mesentery exposed andstraightened.

As indicated at Step D in FIG. 6A, when performed as a laparoscopicprocedure, a pneumoperitoneum is created in the usual fashion and thetrocars are inserted so the procedure may be performed underlaparoscopic guidance with multiple monitors. A partial omentectomy maybe carried out by removing the caudal portions of the omentum. Whenperformed laparoscopically, omentum is removed in strips to facilitateremoval through laparoscopic portals. Care is taken to obtain stricthemostasis and to preserve an apron of protective omentum while it issubstantially shortened and defatted.

FIG. 9A depicts the bowel grasped between two clamps to tent up themesentery. FIG. 9B depicts a cannula inserted into the tented mesenteryto infuse tumescent solution. As indicated in Step E in FIG. 6A, aretractor is inserted through the right lower quadrant and placedposteriorly beneath the tented mesentery. An incision is made anteriorlyin the mesentery, approximately ⅔ of the distance between its base andthe bowel. The surgeon then inserts the power-assisted twin cannulaassembly 5 into the region, and applies 30-40 cm Hg of vacuum to theinner cannula, and conservatively aspirates mesenteric fat. FIG. 9Cdepicts insertion of the twin cannula device 5 into the previouslytumesced and tented mesentery.

When using the laparoscopically-guided twin-cannula visceral fataspiration instrument system shown in FIGS. 1 and 2, there is much lessrisk of vascular disruption or visceral injury than when using singlecannula instrument, because the twin-cannula instrument of the presentinvention protects the adventitia of the arboreal blood vessels frominjury, and allows treatment of larger areas more rapidly andeffectively.

As indicated in Step F in FIG. 6A, the surgeon optionally, appliesbipolar electro-cautery, with or without synchronized tumescence. Byincluding a separate fluidic channel in the outer cannula, extendingfrom its base to its tip, it is possible to synchronize a pulsedinfusion of tumescent solutions or irrigation (e.g. lactated Ringer'ssolution with or without small amounts of epinephrine (e.g.1:100,000-1:400,000) through this additional channel in the tip of thetwin cannula assembly with the advancement of the inner cannula, tofacilitate fat aspiration with a sump effect. Alternatively, a totallyseparate cannula may be placed with the mesentery and used for pulsatileor non-pulsatile, synchronized or unsynchronized infusion near the tipof the twin cannula assembly 5.

By eliminating the battering ram effect of a reciprocating cannula andthe need for tumescent solution for hemostasis, twin cannula visceralfat aspiration allows the minimally invasive removal of soft tissue inany location, including the intestinal mesentery by either open orlaparoscopic approaches. Unlike single cannula visceral fat aspirationcannulas, the tube-within-a-tube construction of the twin cannulaassembly 5 is particularly suited to a laparoscopic approach as allviscera are spared disruption from the moving member except the limitedarea of fat being aspirated in the mesentery adjacent to the outercannula slot. The relatively stationary outer cannula reduces frictioncaused by the continually reciprocating inner cannula and thelaparoscopy portal. Placement of the outer cannula 5A is positional,rather than actively reciprocating, to avulse particles of fat.

Twin cannula mesenteric visceral fat aspiration according to theprinciples of the present invention described above, thus allows directcorrection of abdominal obesity, and in a less invasive and dramaticallyimmediate fashion without the untoward nutritional consequences,hepatic, or renal complications of gastric bypass or banding procedures.

The use of twin cannula visceral fat aspiration, with or without bipolarcautery hemostasis and with or without a synchronized pulsed infusion oftumescent or irrigation solution through the cannula, offers acontrolled, rapid, and safer way of treating a length of intestine withmuch less risk of bleeding or vascular injury.

Although bipolar hemostasis obviates the need for tumescence withepinephrine containing solutions, small amounts of epinephrine could beadded to small pulses of lactated Ringer's solution, with or withoutsmall quantities of local anesthetic, which are synchronized with theadvancement of the inner cannula within the outer cannula.

Since the irrigation solution is immediately aspirated through theaspiration aperture 55 of the twin (twin) cannula assembly 5 of FIG. 2Aand 3A, the systemic effects of vasopressor and local anesthetics duringtwin cannula synchronized tumescence (TCST) would be more limited thanan alternative means, such as infusion of a similarly dilute epinephrineand xylocaine in lactated Ringer's solution with a Tenckoff catheter viaperitoneal lavage.

Epidural or general anesthesia could replace or augment synchronizedinfusion or peritoneal lavage. Although TCST is the preferred embodimentof the described method, the present invention contemplates choosingmodalities that are optimized for each individual patient's physiologicand cardiovascular status, and concentrations of xylocaine andepinephrine in the employed solutions from zero to therapeutic, as thesituation dictates.

As indicated in Step G in FIG. 6B, the surgeon cautiously defats themesentery, leaving skip areas of untreated mesentery every 6-8″ of bowellength to minimize chances of vascular compromise. This step can beachieved by applying a vacuum of 30-40 cm Hg, and defatting themesentery by initiating mechanical reciprocation of the inner cannula 5Bwithin the outer cannula 5A of the transiently stationary twin cannulaassembly 5. Care is taken to retain some fat and avoid creating defectsthat might allow intestine to herniate through, and any perforations inthe mesentery are closed to eliminate this hazard. The area of treatmentis inspected for hemostasis and any defects in the mesentery repaired.The jejunum between clamps is inspected for good vascular supply.

As indicated in Step H IN FIG. 6B, during a single session or duringsmaller, serial sessions, the surgeon defats the mesentery from jejunumto distal ileum, avoiding terminal ileum.

Then, as with the open approach, a small area is skipped much like aradiating spokes on a wheel to assure continuity of blood supply, andthe next 8″ area of jejunum is tented and the procedure repeated untilthe terminal ileum is reached and left untreated. Any difficulties withhemostasis or questionable vascular viability of the bowel indicate thenecessity of a resection and possible conversion to an open procedure.

As indicated in Step I in FIG. 6B, the surgeon repeats the procedure onthe large bowel and/or the small bowel for greatest effect. Themesentery of the large bowel would be approached from the ascendingcolon to the sigmoid colon, avoiding the area surrounding the ileocecalvalve, and the distal sigmoid colon as it descends into the pelvis, andthe mesentery to any areas of large bowel which appear grossly involvedwith diverticulitis.

As indicated in Step J in FIG. 6B, the surgeon performs subsequentsubcutaneous serial, visceral fat aspiration, abdominal lipectomy,dermatolipectomies, and ventral herniorrhaphies, as indicated for bothfunctional and cosmetic indications. Large volume subcutaneous visceralfat aspiration, panniculectomy, abdominoplasty, repair of any ventralhernias or diastasis recti could be carried out in serial sessions toobtain a much tightened abdominal corset for both functional andcosmetic improvement. The majority of these procedures can be performedunder conscious sedation and on an ambulatory basis on these patientswith minimal complications because of their improved metabolic profiles.

As indicated in Step K in FIG. 6B, the surgeon prescribes a diet andexercise program to optimize therapeutic results, and monitorslaboratory parameters and adjust any pharmacologic regimen that had beenpreviously prescribed.

Method of Treating WHR and Metabolic Syndrome According To ThePrinciples of the Present Invention

FIGS. 7A and 7B illustrates the primary steps carried out during theillustrative embodiment of the method of treating WHR and metabolicsyndrome by mesenteric visceral fat aspiration according to the presentinvention, comprising diagnosis, exploration, partial omentectomy, smallbowel mesenteric visceral fat aspiration, large bowel mesentericvisceral fat aspiration, followed by subcutaneous visceral fataspiration, abdominal and dermatolipectomies as indicated.

As indicated in Step A in FIG. 7B, the surgeon diagnoses a patient withmetabolic syndrome and/or obesity, using the waist-to-hip ratio (WHR),by physical measurements and lab tests. Metabolic Syndrome will bediagnosed upon the presence of any Three Risk Factors: Abdominalobesity; Triglycerides; HDL cholesterol; Blood Pressure; and FBS.

Defining levels for males and females are as follows:

-   Female>88 cm (>35″)-   Men:>102 cm.(>40″)-   ≥150 ml/dl-   Men<40mg/dl-   Women<50 mg/dl-   ≥130/≥85 mm Hg-   ≥110 mg/dl

As indicated in Step B in FIG. 7A, the surgeon performs a briefabdominal exploration or inspection to eliminate the presence ofinflammatory bowel disease and other contraindications to surgery, suchas, diverticulitis and a Meckel's diverticulum, or any other pathology.At her option, the surgeon may infuse a tumescent solution (Ringer'slactate with or without dilute epinephrine, and with or withoutxylocaine) as described above to prepare the area for treatment.

As indicated in Step C in FIG. 7A, the surgeon performs a partialomentectomy by removing the redundant omental apron.

As indicated in Step D in FIG. 7A, when performed as an opendirect-viewing procedure, the omentum is retracted and the jejunum isexposed. Either by the hands of an assistant in an open procedure orwith aid of atraumatic laparoscopic graspers [Endo Babcock or DolphinNose Grasper], the proximal jejunum is isolated and placed under gentletension. One atraumatic grasper is inserted in the right upper quadrantfor retraction of the jejunum towards the liver, and a second atraumaticgrasper is inserted in the left lower quadrant, placed on a section ofjejunum approximately 6 to 8 inches distal to the previously placedgrasper, and retracted caudally towards the left lower quadrant. Thejejunum is placed under tension and the mesentery exposed andstraightened.

As indicated at Step D in FIG. 7A, when performed as a laparoscopicprocedure, a pneumoperitoneum is created in the usual fashion and thetrocars are inserted so the procedure may be performed underlaparoscopic guidance with multiple monitors. A partial omentectomy maybe carried out by removing the caudal portions of the omentum. Whenperformed laparoscopically, omentum is removed in strips to facilitateremoval through laparoscopic portals. Care is taken to obtain stricthemostasis and to preserve an apron of protective omentum while it issubstantially shortened and defatted.

FIG. 9A depicts the bowel grasped between two clamps to tent up themesentery. FIG. 9B depicts a cannula inserted into the tented mesenteryto infuse tumescent solution. As indicated in Step E in FIG. 7A, aretractor is inserted through the right lower quadrant and placedposteriorly beneath the tented mesentery. An incision is made anteriorlyin the mesentery, approximately ⅔ of the distance between its base andthe bowel. The surgeon then inserts either a single cannula through theright lower quadrant and into an anterior incision in the jejunalmesentery, and reciprocates it manually, or preferably inserts thepower-assisted twin cannula assembly 5 into the region, and applies30-40 cm Hg of vacuum to the inner cannula, and conservatively aspiratesmesenteric fat. FIG. 9C depicts insertion of the twin cannula device 5into the previously tumesced and tented mesentery.

When using a laparoscopically-guided electro-cauterizing twin-cannulavisceral fat aspiration instrument system shown in FIG. 1, there is muchless risk of vascular disruption or visceral injury than when usingsingle cannula instrument, because the twin cannula instrument protectsthe adventitia of the arboreal blood vessels from injury, and allowstreatment of larger areas more rapidly and effectively.

As indicated in Step F in FIG. 7A, the surgeon optionally, appliesmonopolar or bipolar cautery, with or without synchronized tumescence.By including a separate fluidic channel in the outer cannula, extendingfrom its base to its tip, it is possible to synchronize a pulsedinfusion of tumescent solutions or irrigation (e.g. lactated Ringer'ssolution with or without small amounts of epinephrine (e.g.1:100,000-1:400,000) through this additional channel in the tip of thetwin cannula assembly with the advancement of the inner cannula, tofacilitate fat aspiration with a sump effect. Alternatively, a totallyseparate cannula may be placed with the mesentery and used for pulsatileor non-pulsatile, synchronized or unsynchronized infusion near the tipof the twin cannula assembly 5.

By eliminating the battering ram effect of a reciprocating cannula andthe need for tumescent solution for hemostasis, twin cannula visceralfat aspiration allows the minimally invasive removal of soft tissue inany location, including the intestinal mesentery by either open orlaparoscopic approaches. Unlike single cannula visceral fat aspirationcannulas, the tube-within-a-tube construction of the twin cannulaassembly 5 is particularly suited to a laparoscopic approach as allviscera are spared disruption from the moving member except the limitedarea of fat being aspirated in the mesentery adjacent to the outercannula slot. The relatively stationary outer cannula reduces frictioncaused by the continually reciprocating inner cannula and thelaparoscopy portal. Placement of the outer cannula 5A is positional,rather than actively reciprocating, to avulse particles of fat.

Twin cannula mesenteric visceral fat aspiration (TCML) according to theprinciples of the present invention described above, thus allows directcorrection of abdominal obesity, and in a less invasive and dramaticallyimmediate fashion without the untoward nutritional consequences,hepatic, or renal complications of gastric bypass or banding procedures.

The use of twin cannula visceral fat aspiration, with or without bipolarcautery hemostasis and with or without a synchronized pulsed infusion oftumescent or irrigation solution through the cannula, offers acontrolled, rapid, and safer way of treating a length of intestine withmuch less risk of bleeding or vascular injury.

Although bipolar hemostasis obviates the need for tumescence withepinephrine containing solutions, small amounts of epinephrine could beadded to small pulses of lactated Ringer's solution, with or withoutsmall quantities of local anesthetic, which are synchronized with theadvancement of the inner cannula within the outer cannula.

Since the irrigation solution is immediately aspirated through theaspiration aperture 55 of the twin (twin) cannula assembly 5 of FIG. 2Aor 3A, the systemic effects of vasopressor and local anesthetics duringtwin cannula synchronized tumescence (TCST) would be more limited thanan alternative means, such as infusion of a similarly dilute epinephrineand xylocaine in lactated Ringer's solution with a Tenckoff catheter viaperitoneal lavage.

Epidural or general anesthesia could replace or augment synchronizedinfusion or peritoneal lavage. Although TCST is the preferred embodimentof the described method, the present invention contemplates choosingmodalities that are optimized for each individual patient's physiologicand cardiovascular status, and concentrations of xylocaine andepinephrine in the employed solutions from zero to therapeutic, as thesituation dictates.

As indicated in Step G in FIG. 7B, the surgeon cautiously defats themesentery, leaving skip areas of untreated mesentery every 6-8″ of bowellength to minimize chances of vascular compromise. This step can beachieved by applying a vacuum of 30-40 cm Hg, and defatting themesentery by initiating mechanical reciprocation of the inner cannula 5Bwithin the outer cannula 5A of the transiently stationary twin cannulaassembly 5. Care is taken to retain some fat and avoid creating defectsthat might allow intestine to herniate through, and any perforations inthe mesentery are closed to eliminate this hazard. The area of treatmentis inspected for hemostasis and any defects in the mesentery repaired.The jejunum between clamps is inspected for good vascular supply.

As indicated in Step H IN FIG. 7B, during a single session or duringsmaller, serial sessions, the surgeon defats the mesentery from jejunumto distal ileum, avoiding terminal ileum. Then, as with the openapproach, a small area is skipped much like a radiating spokes on awheel to assure continuity of blood supply, and the next 8″ area ofjejunum is tented and the procedure repeated until the terminal ileum isreached and left untreated. Any difficulties with hemostasis orquestionable vascular viability of the bowel indicate the necessity of aresection and possible conversion to an open procedure.

As indicated in Step I in FIG. 7B, the surgeon repeats the procedure onthe large bowel and/or the small bowel for greatest effect. Themesentery of the large bowel would be approached from the ascendingcolon to the sigmoid colon, avoiding the area surrounding the ileocecalvalve, and the distal sigmoid colon as it descends into the pelvis, andthe mesentery to any areas of large bowel which appear grossly involvedwith diverticulitis.

As indicated in Step J in FIG. 7B, the surgeon performs subsequentsubcutaneous serial, visceral fat aspiration, abdominal lipectomy,dermatolipectomies, and ventral herniorrhaphies, as indicated for bothfunctional and cosmetic indications. Large volume subcutaneous visceralfat aspiration, panniculectomy, abdominoplasty, repair of any ventralhernias or diastasis recti could be carried out in serial sessions toobtain a much tightened abdominal corset for both functional andcosmetic improvement. The majority of these procedures can be performedunder conscious sedation and on an ambulatory basis on these patientswith minimal complications because of their improved metabolic profiles.

As indicated in Step K in FIG. 7B, the surgeon prescribes a diet andexercise program to optimize therapeutic results, and monitorslaboratory parameters and adjust any pharmacologic regimen that had beenpreviously prescribed.

Method of Treating Type II Diabetes According To The Principles of thePresent Invention

FIGS. 8A and 8B illustrate the primary steps carried out during themethod of treating type II diabetes by mesenteric visceral fataspiration according to the illustrative embodiment of the presentinvention, comprising the steps of: diagnosis, exploration, partialomentectomy, small bowel mesenteric visceral fat aspiration, large bowelmesenteric visceral fat aspiration, followed by subcutaneous visceralfat aspiration, abdominal and dermatolipectomies as indicated.

As indicated in Step A in FIG. 8A, the surgeon diagnoses a patient withtype II diabetes by physical measurements and lab tests. Typically, thisdiagnosis is made using Fasting Blood Sugar, Glucose Tolerance orInsulin resistance (hyper insulinemic glucose clamp test, considered tobe the gold standard technique for quantification of insulinsensitivity. [Halaas JL, Gajiwala KS, Maffei M, Cohen SL, et al.:Weight-reducing effects of the plasma protein encoded by the obese gene.Science 269:543,1995]. This test is based on infusing a known dose ofinsulin (1 mU/kg/min) and glucose (20% solution) at a constant speed toachieve a stable plasma concentration of insulin. The plasma glucoselevel is continually determined using a bedside glucose analyzer, andthe exogenous glucose infusion rate is adjusted continually to preventhypoglycemia. Once the steady state is reached, the amount of infusedglucose is the same as that used by the peripheral tissue. Therefore,insulin sensitivity can be calculated as the glucose infusion rate(mg/kg/min) over the last 60 min. A diagnosis of diabetes will be madeif you have a fasting blood sugar level of 126 milligrams per deciliteror higher on two separate days.

Diabetes also may be diagnosed based on a random high glucose level of ³200 mg/dl and symptoms of the disease. The most common glucose tolerancetest is the oral glucose tolerance test (OGTT). The patient cannot eator drink anything after midnight before the test. For the test, thepatient will be asked to drink a liquid containing a certain amount ofglucose. The patient's blood will be taken before s/he does this, andagain every 30 to 60 minutes after s/he drinks the solution. The testtakes up to 3 hours.

Normal blood values for a 75-gram oral glucose tolerance test used tocheck for type 2 diabetes:

-   Fasting: 60 to 100 mg/dL-   1 hour: less than 200 mg/dL-   2 hours: less than 140 mg/dL. Between 140-200 mg/dL is considered    impaired glucose tolerance or pre-diabetes. This group is at    increased risk for developing diabetes. Greater than 200 mg/dL is    diagnostic of diabetes mellitus

As indicated in Step B in FIG. 8A, the surgeon performs a briefabdominal exploration or inspection to eliminate the presence ofinflammatory bowel disease and other contraindications to surgery, suchas, diverticulitis and a Meckel's diverticulum, or any other pathology.At her option, the surgeon may infuse a tumescent solution (Ringer'slactate with or without dilute epinephrine, and with or withoutxylocaine) as described above to prepare the area for treatment.

As indicated in Step C in FIG. 8A, the surgeon performs a partialomentectomy by removing the redundant omental apron.

As indicated in Step D in FIG. 8A, when performed as an opendirect-viewing procedure, the omentum is retracted and the jejunum isexposed. Either by the hands of an assistant in an open procedure orwith aid of atraumatic laparoscopic graspers [Endo Babcock or DolphinNose Grasper], the proximal jejunum is isolated and placed under gentletension. One atraumatic grasper is inserted in the right upper quadrantfor retraction of the jejunum towards the liver, and a second atraumaticgrasper is inserted in the left lower quadrant, placed on a section ofjejunum approximately 6 to 8 inches distal to the previously placedgrasper, and retracted caudally towards the left lower quadrant. Thejejunum is placed under tension and the mesentery exposed andstraightened.

As indicated at Step D in FIG. 8A, when performed as a laparoscopicprocedure, a pneumoperitoneum is created in the usual fashion and thetrocars are inserted so the procedure may be performed underlaparoscopic guidance with multiple monitors. A partial omentectomy maybe carried out by removing the caudal portions of the omentum. Whenperformed laparoscopically, omentum is removed in strips to facilitateremoval through laparoscopic portals. Care is taken to obtain stricthemostasis and to preserve an apron of protective omentum while it issubstantially shortened and defatted.

FIG. 9A depicts the bowel grasped between two clamps to tent up themesentery. FIG. 9B depicts a cannula inserted into the tented mesenteryto infuse tumescent solution. As indicated in Step E in FIG. 8A, aretractor is inserted through the right lower quadrant and placedposteriorly beneath the tented mesentery. An incision is made anteriorlyin the mesentery, approximately ⅔ of the distance between its base andthe bowel. The surgeon then inserts either a single cannula through theright lower quadrant and into an anterior incision in the jejunalmesentery, and reciprocates it manually, or preferably inserts thepower-assisted twin cannula assembly 5 into the region, and applies30-40 cm Hg of vacuum to the inner cannula, and conservatively aspiratesmesenteric fat. FIG. 9C depicts insertion of the twin cannula device 5into the previously tumesced and tented mesentery.

When using a laparoscopically-guided electro-cauterizing twin-cannulavisceral fat aspiration instrument system shown in FIGS. 1A, there ismuch less risk of vascular disruption or visceral injury than when usingsingle cannula instrument, because the twin cannula instrument protectsthe adventitia of the arboreal blood vessels from injury, and allowstreatment of larger areas more rapidly and effectively.

As indicated in Step F in FIG. 8A, the surgeon optionally, appliesmonopolar or bipolar cautery, with or without synchronized tumescence.By including a separate fluidic channel in the outer cannula, extendingfrom its base to its tip, it is possible to synchronize a pulsedinfusion of tumescent solutions or irrigation (e.g. lactated Ringer'ssolution with or without small amounts of epinephrine (e.g.1:100,000-1:400,000) through this additional channel in the tip of thetwin cannula assembly with the advancement of the inner cannula, tofacilitate fat aspiration with a sump effect. Alternatively, a totallyseparate cannula may be placed with the mesentery and used for pulsatileor non-pulsatile, synchronized or unsynchronized infusion near the tipof the twin cannula assembly 5.

By eliminating the battering ram effect of a reciprocating cannula andthe need for tumescent solution for hemostasis, twin cannula visceralfat aspiration allows the minimally invasive removal of soft tissue inany location, including the intestinal mesentery by either open orlaparoscopic approaches. Unlike single cannula visceral fat aspirationcannulas, the tube-within-a-tube construction of the twin cannulaassembly 5 is particularly suited to a laparoscopic approach as allviscera are spared disruption from the moving member except the limitedarea of fat being aspirated in the mesentery adjacent to the outercannula slot. The relatively stationary outer cannula reduces frictioncaused by the continually reciprocating inner cannula and thelaparoscopy portal. Placement of the outer cannula 5A is positional,rather than actively reciprocating, to avulse particles of fat.

Twin cannula mesenteric visceral fat aspiration according to theprinciples of the present invention described above, thus allows directcorrection of abdominal obesity, and in a less invasive and dramaticallyimmediate fashion without the untoward nutritional consequences,hepatic, or renal complications of gastric bypass or banding procedures.

The use of twin cannula visceral fat aspiration, with or without bipolarcautery hemostasis and with or without a synchronized pulsed infusion oftumescent or irrigation solution through the cannula, offers acontrolled, rapid, and safer way of treating a length of intestine withmuch less risk of bleeding or vascular injury.

Although bipolar hemostasis obviates the need for tumescence withepinephrine containing solutions, small amounts of epinephrine could beadded to small pulses of lactated Ringer's solution, with or withoutsmall quantities of local anesthetic, which are synchronized with theadvancement of the inner cannula within the outer cannula.

Since the irrigation solution is immediately aspirated through theaspiration aperture 55 of the twin (twin) cannula assembly 5 of FIG. 2Aor 3A, the systemic effects of vasopressor and local anesthetics duringtwin cannula synchronized tumescence (TCST) would be more limited thanan alternative means, such as infusion of a similarly dilute epinephrineand xylocaine in lactated Ringer's solution with a Tenckoff catheter viaperitoneal lavage.

Epidural or general anesthesia could replace or augment synchronizedinfusion or peritoneal lavage. Although TCST is the preferred embodimentof the described method, the present invention contemplates choosingmodalities that are optimized for each individual patient's physiologicand cardiovascular status, and concentrations of xylocaine andepinephrine in the employed solutions from zero to therapeutic, as thesituation dictates.

As indicated in Step G in FIG. 8B, the surgeon cautiously defats themesentery, leaving skip areas of untreated mesentery every 6-8″ of bowellength to minimize chances of vascular compromise. This step can beachieved by applying a vacuum of 30-40 cm Hg, and defatting themesentery by initiating mechanical reciprocation of the inner cannula 5Bwithin the outer cannula 5A of the transiently stationary twin cannulaassembly 5. Care is taken to retain some fat and avoid creating defectsthat might allow intestine to herniate through, and any perforations inthe mesentery are closed to eliminate this hazard. The area of treatmentis inspected for hemostasis and any defects in the mesentery repaired.The jejunum between clamps is inspected for good vascular supply.

As indicated in Step H in FIG. 8B, during a single session or duringsmaller, serial sessions, the surgeon defats the mesentery from jejunumto distal ileum, avoiding terminal ileum. Then, as with the openapproach, a small area is skipped much like a radiating spokes on awheel to assure continuity of blood supply, and the next 8″ area ofjejunum is tented and the procedure repeated until the terminal ileum isreached and left untreated. Any difficulties with hemostasis orquestionable vascular viability of the bowel indicate the necessity of aresection and possible conversion to an open procedure.

As indicated in Step I in FIG. 8B, the surgeon repeats the procedure onthe large bowel and/or the small bowel for greatest effect. Themesentery of the large bowel would be approached from the ascendingcolon to the sigmoid colon, avoiding the area surrounding the ileocecalvalve, and the distal sigmoid colon as it descends into the pelvis, andthe mesentery to any areas of large bowel which appear grossly involvedwith diverticulitis.

As indicated in Step J in FIG. 8B, the surgeon performs subsequentsubcutaneous serial, visceral fat aspiration, abdominal lipectomy,dermatolipectomies, and ventral herniorrhaphies, as indicated for bothfunctional and cosmetic indications. Large volume subcutaneous visceralfat aspiration, panniculectomy, abdominoplasty, repair of any ventralhernias or diastasis recti could be carried out in serial sessions toobtain a much tightened abdominal corset for both functional andcosmetic improvement. The majority of these procedures can be performedunder conscious sedation and on an ambulatory basis on these patientswith minimal complications because of their improved metabolic profiles.

As indicated in Step K in FIG. 8B, the surgeon ascertains the degree ofmetabolic improvement that has been attained by measuring bloodpressure, lipid profile, adipocytokine and inflammatory markers, fastingblood sugar, or insulin resistance via the hyperinsulimic glucose clamptest previously described, repeating testing at 2 mos/6 mos/9 mos/1yr/1.5 yrs/2 yrs.

Alternative Embodiments Which Readily Come To Mind

While the multi-function twin-cannula assembly described above has beenshown used with a twin cannula assembly, it is understood that inalternate embodiments, the inner cannula can be adapted to provide asimilar fluid infusion channel that terminates proximal to the luerfitting and allows for fluid infusion. As indicated, in twin cannulaembodiments, infusion can be either synchronized. However, in singlecannula embodiments, infusion can be unsynchronized as there will beless advantage and practicality in providing synchronization in a morerapidly reciprocating, short stroke single cannula instrument design.

While a barb Christmas-tree type connector is shown on the stationarytubing connector, of each hand-supportable housing, it is understoodthat the stationary tubing connector may also be realized as a snap-locktype connector for establishing and maintaining a connection with theend portion of flexible aspiration tubing.

Further, the powered fat aspiration instrument of the present inventioncan be designed so that its cylindrical guide tube is made very simple,inexpensively and is disposable so as to eliminate the need for a magnetwhich can lose its strength with autoclaving. The cannula base portioncan be made so as to use washers that are wafer thin, for only one dayof surgery. Such washers can function as diaphragms, staying in placeand deforming to allow to-fro motion of the cylindrical guide tubewithin the cylindrical guide tube. Also, these washers can have anumbrella-shape, or have a thin cylindrical geometry.

Also, while not shown, any embodiment of the power-assisted visceral fataspiration instrument of the present invention can be provided withvarious means along the cannula assembly to effect hemostasis duringliposuction procedures and the like using, for example, RF-based electrocauterization, as taught in Applicant's prior U.S. Pat. Nos. 6,872,199and 7,381,206, incorporated herein by reference.

Several modifications to the illustrative embodiments have beendescribed above. It is understood, however, that various othermodifications to the illustrative embodiment of the present inventionwill readily occur to persons with ordinary skill in the art. All suchmodifications and variations are deemed to be within the scope andspirit of the present invention as defined by the accompanying Claims toInvention.

What is claimed is:
 1. A laparoscopic-based visceral fat tissue aspiration system for treating metabolic syndrome in a human patient by non-invasively and safely removing visceral fat tissue deposits from within a human patient having an abdominal region and a mesenteric region within the body of the human patient to ameliorate metabolic syndrome in the human patient on an ambulatory basis, said laparoscopic-based visceral fat tissue aspiration system comprising: a set of trocars for creating laparoscopy portals through small incisions formed in a human patient's body; a source of inert gas for infusion into the abdominal region of the patient so as to cause tenting of the abdominal region and abdominal distension in a human patient suffering from obesity and likely to benefit from visceral fat removal within the body of the human patient, wherein the human patient has three or more risk factors associated with metabolic syndrome selected from the group consisting of (i) elevated waist-to-hips ratio (Abdominal obesity); (ii) elevated triglycerides, (iii) elevated HDL cholesterol, (iv) hypertension (high Blood Pressure), and (iv) elevated fasting blood sugar (FBS); a laparoscope for insertion through a first one of said trocars and into the abdominal region of the human patient so that a surgeon can capture video images of the abdominal region of the patient, and display the captured video images within the view of the surgeon; a powered tissue aspiration instrument for insertion through a second one of said trocars and into the mesenteric region of the human patient, wherein said tissue aspiration instrument has an instrument housing and a cannula assembly mounted with respect to said instrument housing; and gripping tools for insertion through a third and optionally fourth trocars installed in the patient's abdomen, for gripping anatomical structures in the mesenteric region during visceral fat tissue aspiration operations; wherein said laparoscope is used to capture video images of the mesenteric region of the human patient during visceral fat tissue aspiration operations, and display said video images to provide laparoscopic guidance to the surgeon while aspirating visceral fat tissue from the mesenteric region of the human patient so as to non-invasively and safely remove visceral fat tissue from the mesenteric region of the human patient to reduce three or more risk factors associated with metabolic syndrome.
 2. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said video images of the abdominal region of the patient are displayed on a display screen within the view of the surgeon.
 3. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said instrument housing comprises a hand-held housing adapted to fit within a hand of said surgeon.
 4. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said inert gas comprises CO2 gas infused into the abdominal region of the human patient.
 5. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said powered tissue aspiration instrument comprises a twin-cannula tissue aspiration instrument having a twin cannula assembly including an inner cannula reciprocating within an outer cannula mounted stationary with respect to said instrument housing.
 6. The laparoscopic-based visceral fat tissue aspiration system of claim 5, wherein said twin-cannula tissue aspiration instrument aspirates visceral fat tissue from the mesenteric region of the patient, using while simultaneously infusing a tumescent solution into the mesenteric region of said human patient, through said twin cannula assembly, while synchronizing said infusion of tumescent solution with the forward or return stroke of the inner cannula within said outer cannula, during operation of said twin-cannula aspiration instrument.
 7. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said powered tissue aspiration instrument is used to aspirate visceral fat tissue from the mesenteric region of the patient, while the aspirated visceral fat tissue is collected in a tissue collection device during operation of said tissue aspiration instrument.
 8. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said powered tissue aspiration instrument is driven by a pneumatic motor controlled a source of pressurized air.
 9. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said powered tissue aspiration instrument is driven by an electromagnetic motor controlled a source of electrical power.
 10. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said laparoscope comprises (i) a video probe provided with an embedded 2D high-resolution digital color image sensor with a field of view (FOV) for insertion into the abdominal region of the patient during a visceral fat aspiration operation, (ii) one or more video monitors for displaying to surgeons and assistants, real-time digital color video images of said abdominal region captured along the FOV of said video probe, and (iii) digital recording equipment for recording captured digital video images of said abdominal region during said visceral fat aspiration operation.
 11. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein powered visceral fat aspiration instrument comprises a twin-cannula powered visceral fat aspiration subsystem having a powered hand-supportable fat aspiration instrument having a housing and provided with a bipolar electro-cauterizing twin-cannula assembly including (i) an outer cannula mounted stationary with respect to said housing and having one or more outer aspiration apertures, and (ii) an inner cannula slidably disposed within said outer cannula and having at least one inner aspiration aperture that moves relative to said one or more outer aspiration apertures during operation of said twin-cannula powered visceral fat aspiration subsystem.
 12. The laparoscopic-based visceral fat tissue aspiration system of claim 11, wherein said twin-cannula powered visceral fat aspiration subsystem further comprises a system controller connected to said powered hand-supportable fat aspiration instrument by way of a flexible cable, for supplying (i) pressurized air streams from a pressurized gas source to drive the inner cannula of said powered hand-supportable fat aspiration instrument, or (ii) electrical power signals from an electrical power source to drive said powered hand-supportable fat aspiration instrument.
 13. The laparoscopic-based visceral fat tissue aspiration system of claim 11, wherein RF-power signals are generated by an RF signal generating module and supplied to said bipolar electro-cauterizing twin-cannula assembly.
 14. The laparoscopic-based visceral fat tissue aspiration system of claim 11, which further comprises an infusion pump controlled by said system controller, for periodically or continuously pumping irrigation fluid through an irrigation tube and into an irrigation port provided on said outer cannula for infusing solution near and within the distal tip portion of said outer cannula during system operation.
 15. The laparoscopic-based visceral fat tissue aspiration system of claim 14, wherein said infusion pump supplies a pulsatile flow of irrigation fluid through the distal tip portion of said outer cannula so that controlled amounts of fluid are delivered to the inner cannula under short periods of time to facilitate synchronization.
 16. The laparoscopic-based visceral fat tissue aspiration system of claim 11, which further comprises a multi-spectral illumination source with selectable spectrum control, for delivering a spectrum of illumination along an optical fiber, mounted to said outer cannula, to the distal tip portion of said outer cannula and produce a field of illumination about said inner and outer aspiration apertures of, that spatially overlaps the field of aspiration about said inner and outer aspiration apertures.
 17. The laparoscopic-based visceral fat tissue aspiration system of claim 11, wherein said multi-spectral illumination source generates a red, blue and/or yellow illumination for delivery to the field of aspiration about said inner and outer aspiration apertures, to illuminate tissue about said inner and outer aspiration apertures and help a surgeon visually distinguish arterial vessels, veins and fat, and facilitate visualization of arterial blood vessels, portal and systemic veins and fat, when viewing color digital video images arterial blood vessels, portal and systemic veins and fat being captured by said video probe and displayed by said video monitors during said fat aspiration operation.
 18. The laparoscopic-based visceral fat tissue aspiration system of claim 1, which further comprises: an in-line fat sampling device installed in-line between a vacuum source and said powered hand-supportable fat aspiration instrument, for collecting and indexing samples of visceral fat while a surgeon samples the abdominal region of the patient, for subsequent analysis and testing/measurement for compounds indicative of obesity, metabolic syndrome and/or type II diabetes and selected from the group consisting of Resistin, Angiotensin, Tumor Necrosis Factor (TNF-alpha), Interleukin-6, Adiponectin, and Leptin.
 19. The laparoscopic-based visceral fat tissue aspiration system of claim 1, wherein said housing comprises a hand-supportable housing.
 20. A bariatric surgery operating room configured and operational for treating metabolic syndrome in human patients on an ambulatory basis, said bariatric surgery operating room comprising: a set of trocars for creating laparoscopy portals through small incisions formed in a human patient's body while supported upon an operating table; a source of inert gas for infusion into the abdominal region of the patient so as to cause tenting of the abdominal region and abdominal distension in a human patient suffering from obesity and likely to benefit from visceral fat removal within the body of the human patient, wherein the human patient has three or more risk factors associated with metabolic syndrome selected from the group consisting of (i) elevated waist-to-hips ratio (Abdominal obesity); (ii) elevated triglycerides, (iii) elevated HDL cholesterol, (iv) hypertension (high Blood Pressure), and (iv) elevated fasting blood sugar (FBS); a laparoscope for insertion through a first one of said trocars and into the abdominal region of the human patient so that a surgeon can capture video images of the abdominal region of the patient, and display the captured video images within the view of the surgeon; a powered tissue aspiration instrument for insertion through a second one of said trocars and into the mesenteric region of the human patient, wherein said tissue aspiration instrument has an instrument housing and a cannula assembly mounted with respect to said instrument housing; and gripping tools for insertion through a third and optionally fourth trocars installed in the patient's abdomen, for gripping anatomical structures in the mesenteric region during visceral fat tissue aspiration operations; wherein said laparoscope is used to capture video images of the mesenteric region of the human patient during visceral fat tissue aspiration operations, and display said video images to provide laparoscopic guidance to the surgeon while aspirating visceral fat tissue from the mesenteric region of the human patient so as to treat metabolic syndrome of the human patient by reducing three or more risk factors associated with metabolic syndrome. 